Method and apparatus for reducing body temperature of a subject

ABSTRACT

A cooling system includes a console and a tissue cooling device such as a head-cooling device. An operator applies the head-cooling device to the head of a patient at risk for ischemic injury. The console provides a cooling fluid to a fluid circulation space located between the cooling device and the patient&#39;s head under a positive gage pressure. Direct contact between the cooling fluid and the patient&#39;s head provides a relatively rapid induction of systemic hypothermia in the patient, thereby minimizing or preventing ischemic injury in the patient. The console also removes air from a channel disposed about an inner rim of the cooling device, using a negative gage pressure. Such removal of the air from the channel seals the rim of the cooling device to the head of the patient, including portions of the channel in contact with hair of the patient&#39;s head, and minimizes leaking of the cooling fluid beyond the rim of the cooling device.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/284,114 filed Nov. 21, 2005, which is a continuation of U.S.application Ser. No. 10/706,327 filed Nov. 12, 2003, now U.S. Pat. No.7,052,509 issued May 30, 2006, which claims the benefit of U.S.Provisional Application Ser. No. 60/432,884, filed Dec. 12, 2002, all ofthese applications are hereby incorporated by reference herein.

This application is also related to U.S. application Ser. No. 10/424,391filed Apr. 25, 2003, now U.S. Pat. No. 7,008,445 issued Mar. 7, 2006,which claims the benefit of U.S. Provisional Application Ser. No.60/376,249 filed Apr. 29, 2002. All of these application are also herebyincorporated by reference herein.

BACKGROUND

Patients that suffer from stroke, cardiac arrest, or trauma, such ashead trauma, as well as patients that have undergone invasive brain orvascular surgery, are at risk for ischemic injury. Ischemic injuryoccurs as a result of a lack of oxygen (e.g. lack of oxygenated blood)to an organ, such as caused by a blockage or constriction to a vesselcarrying blood to the organ. For example, in the case where a patientsuffers a heart attack, typically, a clot can block one of the coronaryarteries that carries blood and oxygen to the patient's heart muscle. Asa result of the blockage (e.g., an ischemic condition) the patient'sheart can experience ischemic tissue injury or heart damage. In the casewhere a patient suffers from a stroke, typically, a clot blocks theblood supply to a portion of the patient's brain. The blockage, in turn,causes ischemic damage to the brain tissue. For example, as a result ofthe stroke, the brain experiences a critical or terminal rise inintra-cranial pressure, brain cell death, and a loss of brain function.

Induction of systemic hypothermia (e.g., a hypothermic state) in apatient may minimize ischemic injury when the patient suffers from astroke, cardiac arrest, heart attack, trauma, or surgery. For example,in the case where the patient suffers a heart attack, the effectivenessof hypothermia is a function of the depth (e.g., within a temperaturerange between approximately 30° C. and 35° C. for example) and durationof the hypothermic state as applied to the heart. The effectiveness ofthe hypothermia is also a function of the amount of time that elapsesbetween the original insult (e.g., heart attack) and achievement ofprotective levels of hypothermia. Also, for trauma and stroke patients,hypothermia aids in controlling swelling of the patient's brain.Furthermore, surgeons typically use hypothermia during brain and otherinvasive surgeries to protect the brain from surgical interruptions inblood flow.

Systemic hypothermia has historically been applied, such as by immersionof the patient's body in a cool bath, where the depth and duration ofhypothermia is limited by the patient's ability to tolerate the therapy.Currently, there are several conventional systemic hypothermia systemsavailable. Such conventional systems include blankets or pads wherecooled water is circulated through channels in the walls of the blanketor pad and the patient's body contacts the walls of the blanket.

Attempts have been also made to induce hypothermia in a patient by localcooling the surface of the patient's head. For example, a conventionalhead-cooling device involves a head cap with a gel substance containedwithin the walls of the cap. Prior to use, for example, a user (e.g.,medical technician) places the head-cooling device in a freezer toreduce the temperature of the gel within the cap. During operation, theuser fits the reduced-temperature cap to the head of a patient. The gelwithin the walls of the cap absorbs heat from the head, thereby coolingthe head of the patient.

Other conventional devices induce systemic hypothermia in a patient byproviding contact between a tissue region of interest and a coolingfluid. For example, one conventional device includes a flexible hoodhaving multiple ribs or studs disposed on the inner surface of the hood.When a user places the hood on a head of a patient, the ribs or studscontact the head and maintain a fluid circulation space between the headand the hood and an edge, defined by the hood, contacts the patient'sskin. A negative pressure source draws a cooling fluid through theflexible hood, under negative pressure, to cause the fluid to contactthe scalp of the patient and draw heat away from (e.g., cool) the scalp.Furthermore, application of the negative pressure seals the edges of thehood against the skin of the patient (e.g., a region substantially freeof hair).

SUMMARY

Conventional techniques for providing systemic hypothermia to a patientsuffer from a variety of deficiencies.

As indicated above, systemic hypothermia reduces ischemic injury fromstroke, cardiac arrest, heart attack, trauma, and surgery. However,there are several drawbacks to the approaches described above. Forexample, application of systemic hypothermia can take several hours tolower a patient's body to therapeutic temperatures. Such a time perioddelays achieving therapeutic temperatures within the patient and,therefore, allows the progression of irreversible injury to the brain orheart. In another drawback to known systemic hypothermia systems,systemic hypothermia cannot be initiated until after the patient hasbeen admitted to the hospital.

As indicated above, attempts have been made to induce systemichypothermia by using head-cooling devices to cool the surface of thehead, such as a head cap with a gel substance contained within the wallsof the cap. For example, during operation, the user fits thereduced-temperature cap to the head of a patient. The gel within thewalls of the cap absorbs heat from the head, thereby cooling the head ofthe patient. Reports from clinical trials using such devices indicate,however, that while these devices induce systemic hypothermia, suchinduction is performed at a relatively slow rate. A significant problemis that hair, especially dry hair, is a very effective insulator. Thereis significant variation from patient to patient in the thickness ofhair on the head and its distribution on the head. A device that doesnot address the insulating effect of hair, and its variability amongpatients will be ineffective in rapidly inducing systemic hypothermia ina patient.

A second significant deficiency with conventional head-cooling devicesrelates to the separation of the cooling medium (e.g., gel orcirculating water) from the head by a material forming the device.Typically, head-cooling devices are made of plastic or woven material,both of which are highly insulative and greatly reduce the amount ofheat that is transferred from the head into the cooling medium.

Also as indicated above, conventional head-cooling devices include aflexible hood placed on the head of a patient. A cooling fluid is drawnthrough the flexible hood under negative pressure to contact the scalpof the patient and draw heat away from (e.g., cool) the patient's scalp.Because the flexible hood, however, relies on a negative pressure todraw the cooling fluid within a region between the scalp and the hoodapparatus, a large number of regularly spaced ribs or studs are requiredto form fluid channels between the scalp and the apparatus. Furthermore,application of the negative pressure seals the edges of the hood againstthe skin of the tissue region. However, such sealing is ineffective whenthe edges are positioned over hair, such as hair protruding from apatient scalp. In the case where the edges contact the hair of apatient's scalp, the hair minimizes the seal between the hood and thepatient, thereby allowing leakage of the cooling fluid from the hoodapparatus.

By contrast, embodiments of the present invention significantly overcomesuch deficiencies and provide techniques for inducing systemichypothermia in a patient. A cooling system includes a console and atissue cooling device, such as a head-cooling device. An operatorapplies the head-cooling device to the head of a patient at risk forischemic injury. The console provides a cooling fluid to a fluidcirculation space located between the cooling device and the patient'shead under a positive gage pressure. Direct contact between the coolingfluid and the patient's head provides a relatively rapid induction ofsystemic hypothermia in the patient, thereby minimizing or preventingischemic injury in the patient. The console also removes air from achannel disposed about an inner rim of the cooling device, using anegative gage pressure. Such removal of the air from the channel sealsthe rim of the cooling device to the head of the patient, includingportions of the channel in contact with hair of the patient's head, andminimizes leaking of the cooling fluid beyond the rim of the coolingdevice.

In one arrangement, the invention relates to a cooling device forinducing hypothermia. The head-cooling device includes a cap having anouter surface and an inner surface. The head-cooling device has a firstsealing member disposed on the inner surface of the cap about acircumference defined by the cap. The first sealing member defines afirst inner surface of the cap and a second inner surface of the capwhere the first sealing member, the first inner surface of the cap, anda first portion of a head define a fluid circulation space. Thehead-cooling device has a second sealing member disposed on the secondinner surface of the cap about a rim defined by the cap where the firstsealing member, the second inner surface of the cap, and the secondsealing member define an aspiration channel. The head-cooling device hasa fluid inlet in communication with the fluid circulation spaceconfigured to receive a cooling fluid from a fluid source via a positivegage pressure and an aspiration channel outlet in communication with theaspiration channel. The aspiration channel is configured to remove airfrom the aspiration channel, via a negative gage pressure, to seal therim of the cap to a second portion of the head. Such a configuration ofthe head-cooling device induces systemic hypothermia in a patient andminimizes leakage of the cooling fluid past the rim of the head-coolingdevice.

In one arrangement, the aspiration channel is configured to retrievefluid from the fluid circulation space and the aspiration channel outletis configured to remove fluid retrieved by the aspiration channel. Inanother arrangement, the head-cooling device includes a fluid collectionreservoir in communication with the cap, the fluid collection reservoirin fluid communication with the fluid circulation space and in fluidcommunication with the aspiration channel.

In one arrangement, the head-cooling device includes a fluid outlet incommunication with the cap and in fluid communication with the fluidcirculation space, the fluid outlet configured to allow egress of thecooling fluid from the fluid circulation space. Such a configurationallows removal of the fluid from the fluid circulation space viagravity. In one arrangement, the head-cooling device defines a ventopening within the cap, the vent opening configured to maintain thepressure within the fluid circulation space at substantially atmosphericpressure.

In one arrangement the head-cooling device is coupled with a tissuecooling device, such as a body-cooling device that provides additionalcooling to a patient to induce systemic hypothermia in the patient. Thebody-cooling device includes a fluid distribution membrane defining aplurality of fluid jets and a heat transfer membrane attached to thefluid distribution membrane and configured to cover a body portion, thefluid distribution membrane and the heat transfer membrane defining afluid circulation chamber. In one arrangement, the jets create fluidturbulence within the fluid circulation chamber. Such turbulenceincreases the heat transfer between a cooling fluid within the fluidcirculation chamber and the heat transfer membrane, thereby providingrelatively rapid and efficient cooling to the body portion.

In one arrangement, the body-cooling device is configured as aneck-cooling device having a collar, a first body-cooling moduleattached to the collar, and a second body-cooling module attached to thecollar. The first body-cooling module has a first fluid distributionmembrane defining a plurality of fluid jets and has a first heattransfer membrane attached to the first fluid distribution membraneconfigured to cover a first neck portion. The first fluid distributionmembrane and the first heat transfer membrane define a first fluidcirculation chamber. The second body-cooling module has a second fluiddistribution membrane defining a plurality of fluid jets and has asecond heat transfer membrane attached to the second fluid distributionmembrane configured to cover a second neck portion. The second fluiddistribution membrane and the second heat transfer membrane define asecond fluid circulation chamber.

In one arrangement, the cap comprises a flexible material and thehead-cooling device comprises a substantially rigid shell incommunication with the outer surface of the cap. The rigid shellminimized expansion or “ballooning” of the cap when, for example, apositive gage pressure source applies a positive gage pressure to thefluid circulation space.

In one arrangement, the fluid inlet and the fluid outlet each include aswivel joint configured to allow rotation of an inlet connector relativeto the head-cooling device. The swivel joints, therefore, minimizekinking of an umbilical connecting the head-cooling device to a console(e.g., a console having a positive gage pressure source and a negativegage pressure source) during operation.

In one arrangement, the head-cooling device includes a movementstabilizer component in communication with the outer surface of the cap.The movement stabilizer component contacts a support surface (e.g., agurney or stretcher) and minimizes rotation of the patient's head duringoperation of the head-cooling device.

In one arrangement, the aspiration channel defined by the first sealingmember, the second inner surface of the cap, and the second sealingmember includes a fluid absorption material, such as a sponge or foam.The absorption material, for example, aids in directing the fluid fromthe fluid circulation space into the aspiration channel and maintainsthe fluid within the aspiration channel to minimize leakage of thefluid.

In one arrangement, the head-cooling device has a third sealing memberdisposed on the inner surface of the cap about a circumference definedby the cap, the third sealing member oriented between the first sealingmember and the second sealing member. The third sealing member creates asecondary seal between a patient's head and the head-cooling deviceduring operation to minimize cooling fluid from flowing beyond the rimof the head-cooling device during operation.

Another aspect of this invention relates to a method for rapidlyinducing systemic hypothermia in a patient's body to a predeterminedtemperature and then maintaining the patient's body at the predeterminedtemperature for an extended period of time. The head of the patient iscooled by a head-cooling device. Substantially simultaneously, the neckof the patient is cooled using a neck-cooling device for a period oftime sufficient for at least some part of the patient's body to reachthe predetermined temperature. Head cooling is then discontinued byde-activating or removing the head-cooling device from the patient'shead. Neck cooling is continued in a manner sufficient to maintain atleast some portion of the patient's body at the predeterminedtemperature for an extended period of time.

In one arrangement, the invention relates to a tissue cooling device forinducing hypothermia. The tissue cooling device has a tissue coveringportion having an outer surface and an inner surface and a first sealingmember disposed on the inner surface of the tissue covering portionabout an inner edge defined by the tissue covering portion. The firstsealing member defines a first inner surface of the tissue coveringportion and a second inner surface of the tissue covering portion, thefirst sealing member, the first inner surface of the tissue coveringportion, and a first portion of a tissue region of interest define afluid circulation space. The tissue cooling device has a second sealingmember disposed on the second inner surface of the tissue coveringportion about an outer edge defined by the tissue covering portion. Thefirst sealing member, the second inner surface of the tissue coveringportion, and the second sealing member define an aspiration channel. Thetissue cooling device has a fluid inlet in communication with the fluidcirculation space that is configured to receive a cooling fluid from afluid source via a positive gage pressure. The tissue cooling device hasan aspiration channel outlet in communication with the aspirationchannel that is configured to remove air from the aspiration channel,via a negative gage pressure, to seal the outer edge of the tissuecovering portion to a second portion of the tissue region of interest.Such sealing of the outer edge of the tissue covering portion to asecond portion of the tissue region of interest minimizes leaking of thecooling fluid beyond the outer edge of the tissue covering portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of theinvention will be apparent from the following description of particularembodiments of the invention, as illustrated in the accompanyingdrawings in which like reference characters refer to the same partsthroughout the different views. The drawings are not necessarily toscale, emphasis instead being placed upon illustrating the principles ofthe invention.

FIG. 1 depicts a cooling system showing a head-cooling device, aneck-cooling device, a body temperature sensor, and a console, accordingto one embodiment of the invention.

FIG. 2 depicts the head-cooling device of FIG. 1, according to oneembodiment of the invention.

FIG. 3 depicts a sectional-view of the head-cooling device of FIG. 2,according to one embodiment of the invention.

FIG. 4 depicts the head-cooling device in sectional view mounted on thehead of a patient, according to one embodiment of the invention.

FIG. 5A depicts a side view of a body-surface cooling module underoperational pressure, according to one embodiment of the invention.

FIG. 5B depicts a front view of the body-surface cooling module, of FIG.5A, under operational pressure, according to one embodiment of theinvention.

FIG. 6 depicts a sectional view of the body-surface cooling module ofFIG. 5A showing the operational relationship between a heat transfermembrane, a cooling fluid distribution membrane, a fluid circulationspace, fluid jets, and fluid channels.

FIG. 7A depicts a side view of a body-surface cooling module, accordingto another embodiment of the invention.

FIG. 7B depicts a sectional view of the body-surface cooling module ofFIG. 7A showing the fluid jets and the cooling fluid outlet port.

FIG. 8A depicts a side view of a body-surface cooling module, accordingto another embodiment of the invention.

FIG. 8B depicts a sectional view of the body-surface cooling module ofFIG. 8A showing the fluid manifold, cooling fluid inlet port, andcooling fluid outlet port.

FIG. 9A depicts a side view of a neck-cooling device, according to oneembodiment of the invention.

FIG. 9B depicts a front view of the neck-cooling device of FIG. 9A,according to one embodiment of the invention.

FIG. 10A depicts a side view of a body-surface cooling appliance havingmultiple body-surface cooling modules, according to one embodiment ofthe invention.

FIG. 10 B depicts a top view of the body-surface cooling appliance ofFIG. 10A, according to one embodiment of the invention.

FIG. 10C depicts a front view of the body-surface cooling appliance ofFIG. 10A, according to one embodiment of the invention.

FIG. 11A depicts a schematic of a console, according to one embodimentof the invention.

FIG. 11B depicts a schematic of the console, according to anotherembodiment of the invention.

FIG. 11C depicts a sectional view of a thermal battery, according to oneembodiment of the invention.

FIG. 11D depicts a sectional view of a fluid reservoir.

FIG. 12 illustrates a head-cooling device, according to anotherembodiment of the invention.

FIG. 13 depicts a sectional view of the head-cooling device of FIG. 12,according to one embodiment of the invention.

FIG. 14 depicts the head-cooling device of FIG. 12 in sectional viewmounted on the head of a patient, according to one embodiment of theinvention.

FIG. 15 depicts a schematic of a console, according to anotherembodiment of the invention.

FIG. 16 illustrates a perspective view of the head-cooling device ofFIG. 12, according to one embodiment of the invention.

FIG. 17 illustrates the head-cooling device having a rigid outer shell,according to one embodiment of the invention.

FIG. 18 illustrates the head-cooling device having an inlet swiveljoint, according to one embodiment of the invention.

FIG. 19 illustrates the head-cooling device having handles, according toone embodiment of the invention.

FIG. 20 illustrates the head-cooling device having a fluid inletpositioned in proximity to a fluid outlet, according to one embodimentof the invention.

FIG. 21 illustrates a side view of the head-cooling device having astabilizer mechanism, according to one embodiment of the invention.

FIG. 22 illustrates the head-cooling device of FIG. 21, according to oneembodiment of the invention.

FIG. 23 illustrates the head-cooling device having a fluid distributionmanifold, according to one embodiment of the invention.

FIG. 24 illustrates the fluid distribution manifold of FIG. 23,according to one embodiment of the invention.

FIG. 25 illustrates a sectional view of an arm of the fluid distributionmanifold of FIG. 23, according to one embodiment of the invention.

FIG. 26 illustrates the head-cooling device having a third sealingmember, according to one embodiment of the invention.

FIG. 27 illustrates the third sealing member of FIG. 26, according toone embodiment of the invention.

FIG. 28 illustrates the head-cooling device having a wicking materialwithin a channel of the head-cooling device, according to one embodimentof the invention.

FIG. 29 illustrates the head-cooling device having flow channels,according to one embodiment of the invention.

FIG. 30 illustrates the head-cooling device of FIG. 29, according to oneembodiment of the invention.

FIG. 31 illustrates a fluid collection reservoir for a head-coolingdevice, according to one embodiment of the invention.

FIG. 32 illustrates a side sectional view of a head-cooling device 1,according to one embodiment of the invention.

FIG. 33 illustrates a top view of the head-cooling device of FIG. 32,according to one embodiment of the invention.

FIG. 34 illustrates an umbilical for use with the head-cooling device ofFIG. 32, according to one embodiment of the invention.

FIG. 35 illustrates a console, according to one embodiment of theinvention.

FIG. 36 illustrates a flowchart of a procedure for using a coolingsystem, according to one embodiment of the invention.

FIG. 37 illustrates a flowchart of a cooling system, according toanother embodiment of the invention.

FIG. 38 illustrates an arrangement of the cooling system, according toone embodiment of the invention.

FIG. 39 illustrates an arrangement of an inner liner of the cooling capof FIG. 38, according to one embodiment of the invention.

FIG. 40 illustrates a front view of the cooling collar of FIG. 38,according to one embodiment of the invention.

FIG. 41 illustrates a side view of the cooling collar of FIG. 38,according to one embodiment of the invention.

FIG. 42 illustrates a sectional view of the cooling collar of FIG. 38,according to one embodiment of the invention.

DETAILED DESCRIPTION

Embodiments of the present invention provide techniques for inducingsystemic hypothermia in a patient. A cooling system includes a consoleand a tissue covering device, such as a head-cooling device. An operatorapplies the head-cooling device to the head of a patient at risk forischemic injury. The console provides a cooling fluid to a fluidcirculation space located between the cooling device and the patient'shead under a positive gage pressure. Direct contact between the coolingfluid and the patient's head provides a relatively rapid induction ofsystemic hypothermia in the patient, thereby minimizing or preventingischemic injury in the patient. The console also removes air from achannel disposed about an inner rim of the cooling device, using anegative gage pressure. Such removal of the air from the channel sealsthe rim of the cooling device to the head of the patient, includingportions of the channel in contact with hair of the patient's head, andminimizes leaking of the cooling fluid beyond the rim of the coolingdevice.

FIG. 1 depicts an arrangement of a cooling system 100. The coolingsystem includes a tissue covering device, such as a head-cooling device1, a console 2, a tissue covering device, such as a body-cooling device6, and a body temperature sensor 10.

The head-cooling device 1, in one arrangement, is removably connected toconsole 2 by umbilical 3 having, for example, a cooling fluid infusiontube 4 and a cooling fluid aspiration tube 5. The body-cooling device 6,such as a neck-cooling device 90, is removably connected to console 2 byumbilical 7 having, for example, a cooling fluid inlet tube 8 and acooling fluid outlet tube 9.

The body temperature sensor 10, in one arrangement, is removablyconnected to console 2 by a body temperature sensor lead 11. The bodytemperature sensor 10 is configured to attach onto (e.g., on an outersurface) or within (e.g., within a natural orifice) a patient's body tomeasure the temperature of the patient during operation of the coolingsystem 100. In one arrangement, the body temperature sensor 10 is anesophageal temperature sensor configured to insert within an esophagusof a patient to measure core body temperature. In another arrangement,the body temperature sensor in a bladder temperature sensor or atympanic temperature sensor configured to insert within a bladder orear, respectively, of a patient.

The console 2 has a cooling fluid supply, such as a reservoir 56, forprovision of cooling fluid to the head-cooling device 1 and thebody-cooling device 6 under positive gage pressure (e.g., from apressure source or positive gage pressure source, such as a water pump,associated with the console 2). The console 2 also has, in onearrangement, a suction source or negative gage pressure source, such asan air pump, configured to scavenge cooling fluid from head-coolingdevice 1 and neck-cooling device 90. The console 2 also has, in onearrangement, a fluid cooling mechanism for cooling the fluid (e.g.,after scavenging the cooling fluid from the head-cooling device 1 andthe body-cooling device 6) and a flow rate adjustment mechanism toadjust the flow of cooling fluid from console 2 to the head-coolingdevice 1 and the body-cooling device 6 according to signals receivedfrom the body temperature sensor 10, during operation, in order tocontrol body cooling (e.g., the duration of application of cooling fluidto the patient during operation of the cooling system 100). In onearrangement, the console 2 has a handle 14 that allows a user to graspand transport the console 2 to a patient.

In one arrangement, electrical power is supplied to the console 2 by aninternal power source, such as a rechargeable battery (e.g., such asillustrated in FIG. 11), and by an external power source connected tothe console 2 by an AC power adapter (not shown). The battery allows auser (e.g., operator or emergency technician) to transport the coolingsystem 100 to a patient at risk for ischemic injury at a locationoutside of a hospital (e.g., at an emergency site where an externalpower source or supply, such as provided from a wall outlet, isunavailable). For example, during operation, the console 2 providescooling to a patient for greater than approximately 5 hours usinginternal power source. The console 2 then provides cooling to thepatient for an indefinite time period using power from an external powersupply, such as a wall outlet (e.g., after the patient is transferred toa patient care facility).

During operation, upon presentation of a patient with an ischemiccondition, the cooling system 100 is applied to the patient. Forexample, the head-cooling device 1 is placed on top of the patient'shead and is secured using a chinstrap 12. The neck-cooling device 90 isapplied to the patient's neck, such as by using Velcro fasteners (seeFIG. 9 for construction details). The body temperature sensor 10 isapplied to the surface of the patient or inserted into a natural orificeof the patient (e.g., this step can be accomplished at a later time. Inanother arrangement, the system operates without the temperature sensor10 prior to the patient's body reaching a pre-determined temperature).The head-cooling device 1, the neck-cooling device 90, and the bodytemperature sensor 10 are connected to the console 2.

The fluid reservoir 56, as shown in FIG. 12, is filled with a coolingfluid, such as saline and brine ice, water and ice, saline, or water,for example. A user activates the system 10 by positioning the on/offswitch 13 to the “on” position. In one arrangement, the console 2 of thecooling system 100 provides cooling fluid to the head-cooling device 1via positive gage pressure and removes fluid from the head-coolingdevice 1 via negative gage pressure. The cooling system 100 utilizes thebody temperature sensor 10 (e.g., measurements taken by the temperaturesensor 10) to modulate cooling (e.g., provision of cooling fluid to thepatient) in order to maintain the patient's body at a predeterminedhypothermic temperature. For example, the console 2 provides coolingfluid to the head-cooling device 1 until the patient's body reaches apredetermined (e.g., preset) hypothermic temperature, as measured by thebody temperature sensor 10, at which time the system modulates coolingby modulating the flow of cooling fluid to the head-cooling device 1 andthe body-cooling device 6 according to signals received from bodytemperature sensor 10.

In one arrangement, the console 2 forms a closed loop fluid circulationsystem between the head-cooling device 1 and the reservoir 56 of theconsole 56. Such a closed loop system allows continuous cooling of thecooling fluid, such as by a thermal battery 342, as described below. Inanother arrangement, a user can operate the cooling system 100 for anextended period of time by re-supplying the reservoir 56 with brine iceor ice to reduce the temperature of the cooling fluid within thereservoir 56.

The cooling system 100 allows for relatively rapid induction of systemichypothermia to a patient at risk of ischemic injury for minimization orprevention of ischemic injury in the patient. For example, the coolingsystem 100 allows for induction of protective levels of hypothermia in abrain of a patient at risk of ischemic injury. The cooling system 100also allows for non-invasive application and induction of systemichypothermia in the pre-hospital setting by emergency medical personnelwith minimal specialized (e.g., surgical) skills.

The cooling system 100 allows emergency medical personnel, in thepre-hospital setting, to relatively rapidly induce of systemichypothermia in a patient to a predetermined temperature and maintain thesystemic hypothermia for an extended period of time (e.g., after thepatient arrives at the hospital). In one arrangement, the console 2 issized to allow for portability of the cooling system 100 outside of thehospital setting to minimize ischemic injury in patients at-risk forischemic injury prior to the patients arriving at the hospital.

FIG. 2 depicts an arrangement of the head-cooling device 1. Head-coolingdevice 1 includes a tissue covering portion, such as a head cap 15, achinstrap 12, cooling fluid infusion tube 4, cooling fluid aspirationtube 5 (e.g., two bifurcated cooling fluid aspiration tubes 5 are shownwhich join into a single tube by a “Tee” connector—not shown), infusionmanifold 16, and one or more aspiration manifolds 17 (e.g., aspirationchannel outlets 252). Cooling fluid enters head-cooling device 1 throughcooling fluid infusion tube 4 and infusion manifold 16 under positivegage pressure between approximately 2 and 40 PSI. In one arrangement,cooling fluid is removed from head-cooling device 1 by cooling fluidaspiration tubes 5 and aspiration manifold 17 under negative gagepressure between approximately −0.1 and −10 PSI. Head cap 15 can beformed from either a rigid structure molded from thermoplastic, such asnylon, vinyl, polycarbonate, or from a flexible structure molded from anelastomer such as silicone rubber. Chinstrap 12 holds head-coolingdevice 1 to the patient's head.

FIG. 3 depicts, in sectional view, an arrangement of the head-coolingdevice 1. The head cooling device 1 has a head cap 15 having an innerwall 19 having an inner surface 102, an outer wall 24 having an outersurface 104, fluid channels 18 formed between inner wall 19 and outerwall 24, and fluid jets 20 formed in inner wall 19 over fluid channels18.

The head-cooling device 1 has a first sealing member or inner seal 22disposed on the inner surface 102 of the cap 15 about an inner edge orcircumference defined by the cap 15. The first sealing member 22 divides(e.g., defines) the inner surface 102 of the cap 15 into a first innersurface 106 and a second inner surface 108. In such a configuration, thefirst sealing member 22, the first inner surface 102 of the cap 15, anda first portion of a patient's head defines a fluid circulation space25. The head-cooling device 1 also has a second sealing member 23disposed on the second inner surface 108 of the cap 15 about an outeredge or rim 110 defined by the cap. In such a configuration, the firstsealing member 22, the second inner surface 108 of the cap 15, and thesecond sealing member 23 define an aspiration channel, an aspirationchannel 21.

The head-cooling device 1 has a fluid inlet 112, such as infusionmanifold 16, in communication with the fluid circulation space 25 andconfigured to receive a cooling fluid from a fluid source via a positivegage pressure. In one arrangement, the infusion manifold 16 is bonded tothe head cap 15 or, alternately is integrally molded into head cap 15.The infusion manifold 16 provides fluid communication between coolingfluid infusion tube 4 (e.g., in fluid communication with the positivegage pressure source) and fluid channels 18.

The head-cooling device 1 has an aspiration channel outlet, such asaspiration manifolds 17, in communication with the aspiration channel21. The aspiration channel outlet is configured to remove air from theaspiration channel 21, via a negative gage pressure, to seal the rim 110of the cap 15 to a second portion 118 of the head 29. In onearrangement, the aspiration manifolds 17 are bonded to head cap 15 or,alternately, are integrally molded into head cap 15. The aspirationmanifolds 17 provide fluid communication between cooling fluidaspiration tube 5 (e.g., in fluid communication with the negative gagepressure source) and aspiration channel 21.

Fluid channels 18 distribute cooling fluid substantially throughout thehead cap 15 and communicate cooling fluid from infusion manifold 16 to,in one arrangement, fluid jets 20 that direct streams of cooling fluidat an angle substantially normal to the scalp of the patient. The fluidchannels 18, in one arrangement, are configured in a radial fashionwhere each channel 18 originates at the infusion manifold 16 andterminates prior to the aspiration channel 21 as shown. In anotherarrangement, the fluid channels 18 are configured as a series ofcircumferential channels in combination with radial channels. The fluidchannels 18 are configured to provide distribution of cooling fluidthrough a substantially even distribution of fluid jets 20 throughoutthe head cap 15. In one arrangement, the fluid jets 20 are formed asperforations or holes in the inner wall 19 and are closed until pressureis applied. For example, the holes have a major diameter betweenapproximately 0.005 and 0.030 inches. The fluid channels 18 providedistribution of the fluid to the patient's head such that the thicknessor distribution of the hair on the head, face, or neck of the patientdoes not substantially affect (e.g., limit) cooling of the patient'shead (e.g., does not substantially affect induction of hypothermia).

FIG. 4 depicts, in one arrangement, a sectional view of the head-coolingdevice mounted on the head 29 of a patient showing the cooling fluidcirculation space 25, the cooling fluid aspiration space 26, and thefunctional relationship between the cooling fluid circulation space 25and the cooling fluid aspiration space 26. Cooling fluid circulationspace 25 comprises the volumetric space between inner wall 19 (e.g., thefirst inner surface 102 of the cap 15), patient's scalp 28 (e.g., thefirst portion of the head 116 or first portion of the tissue region ofinterest), and inner seal 22 (e.g., the first sealing member), andincludes the volumetric space occupied by the patient's hair 27 withinthe defined cooling fluid circulation space 25.

In one arrangement, during operation, the console 2 of the coolingsystem 100 (e.g., the positive gage pressure source) maintains the fluidcirculation space 25 (e.g., the region over the scalp and between thescalp and the head-cooling device 1) at a positive gage pressure.Typically, substantial contact between an inner surface 102 of ahead-cooling device and the scalp results in diminished heat transfereffectiveness due to a reduction in the surface area of the scalpavailable for heat exchange with the cooling fluid. Positive gagepressure within the fluid circulation space 25 limits the ability forthe inner surface 102 of the head-cooling device 1 to contact thepatient's scalp (e.g., head), thereby maximizing the efficiency of thecooling fluid with respect to removal of heat from the patient's head29.

Cooling fluid aspiration space 26 includes the volumetric space betweenthe patient's scalp 28 (e.g., the second portion of the head 118 orsecond portion of the tissue region of interest) and a space withinaspiration channel 21 comprising inner seal 22, outer seal 23 and secondinner surface 108. The aspiration channel 21, in one arrangement, ismolded from an elastomer material such as silicone rubber. Theaspiration channel 21, in one arrangement, is disposed about the entirecircumference of the inner surface 102 at the bottom edge 110 (e.g.,rim) of the head cap 15 as shown and, in one arrangement, is sized suchthat the inner diameter of aspiration channel 21 as defined by the innerdiameter of inner seal 22 and/or outer seal 23 is approximately 2 to 30percent smaller than the circumference of the patient's head 29. Sincethe circumference of the aspiration channel 21 is smaller than thepatient's head 29, when the head cap 15 is placed on the patient's head,the inner seal 22, and the outer seal 23 contacts the patient's scalp 28with a force proportional to the difference in circumference betweenthat aspiration channel 21 and the patient's head 29. In such anarrangement, the force generated by the aspiration channel 21 on thepatient's head maintains the head cap 15 on the patient's head 29 duringoperation of the cooling system 100 and minimizes cooling fluid fromleaking past the rim 110 of the head cap 15 during operation.

In one arrangement, the inner seal 22 is configured by geometry andmaterial selection to resist the flow of fluid from fluid circulationspace 25 through the hair 27 into fluid aspiration space 26 such thatcooling fluid in fluid circulation space 25 remains at a positive gagepressure between approximately 0.1 and 10 PSI with a fluid flow intohead cap 15 of between 0.1 and 1.0 gallons per minute. The outer seal23, in one arrangement, is configured by geometry and material selectionto resist the flow of air through the hair 27 from outside head cap 15into aspiration channel 21 such that, during operation, pressure withinaspiration channel 21 is maintained at a negative gage pressure betweenapproximately −0.1 and −10 PSI by the negative gage pressure sourceprovided by console 2. Cooling fluid is scavenged completely from thehead cap 15, via aspiration channel outlet, provided that the pressurewithin the aspiration channel 21 remains at a negative gage pressure.

For example, during operation the positive gage pressure source of theconsole 2 provides cooling fluid, under positive gage pressure, to thecooling device via inlet 112. The cooling fluid enters the infusionmanifold 16 and travels through the fluid channels 18 and, in onearrangement, through the fluid jets 20, into the fluid circulation space25.

The positive gage pressure source aids in maintaining the pressurewithin the fluid circulation space 25 between approximately 0.1 and 10PSI. Also during operation, the negative gage pressure source of theconsole 2 removes air from within the aspiration channel 21 (e.g., fromwithin the aspiration space), thereby sealing the rim 110 of the cap 15against the second portion 118 of the head (e.g., a periphery of thetissue region of interest) to minimize leakage of the cooling fluidbeyond the rim 110 of the cap 15.

In one arrangement, the aspiration channel 21 receives cooling fluidfrom the fluid circulation space 25. For example, during operationcooling fluid enters the aspiration channel 21 by wicking through thepatient's hair past the first sealing member 22 (e.g., cooling fluidfrom the fluid circulation space 25 migrates, via the hair between thefirst portion 116 of the head and the second portion 118 of the head,into the aspiration channel 21). In such a case, the negative gagepressure applied to the aspiration channel 21 removes the cooling fluidfrom the aspiration channel 21 via the aspiration channel outlet (e.g.,manifold 17). The aspiration channel 21, therefore, minimizes leakage ofthe cooling fluid beyond the rim 110 of the cap 15.

FIG. 5A depicts a side view of generic body-surface cooling module 30(e.g., tissue covering portion) of a tissue cooling device configured asa body-cooling device 6 under operational pressure. FIG. 5B depicts afront view of a generic body-surface cooling module 30 under operationalpressure. The body-surface cooling module 30, in one arrangement,includes substrate 31, fluid distribution membrane 32, heat transfermembrane 33, fluid inlet fitting 34, fluid inlet tube 35, fluid outletfitting 36 containing fluid outlet pressure relief valve 37 (not shown),and fluid outlet tubing.

During operation, cooling fluid (not shown) enters body-surface coolingmodule 30 at a gage pressure between approximately 5 and 20 PSI throughfluid inlet tube 35 and fluid inlet fitting 34. Fluid distributionmembrane 32 directs jets of cooling fluid at the side of heat transfermembrane 33 that is opposite the side shown (see FIGS. 6, 7, 8 & 9 forconstruction details). Cooling fluid exits body-surface cooling module30 through fluid outlet pressure relief valve 37, fluid outlet fitting36, and fluid outlet tube 38. Fluid outlet pressure relief valve isconstructed such that a backpressure is maintained in the body-surfacecooling module between approximately 0.2 and 5 PSI gage. Back pressureswithin body-surface cooling module 30 causes heat transfer membrane 33to distend and contact a body surface of the patient. The constructionof substrate 31 is determined by the location on the patient's bodywhere the body-surface cooling module 30 is to be applied. The substrate31, in one arrangement, is configured with straps and fasteners havingparticular geometric shapes in order to accommodate specific parts ofthe body. For example, FIG. 9 depicts a substrate comprising a collarintended for neck cooling.

FIG. 6 depicts in sectional view the construction details andoperational function of a generic body-surface cooling module 30.Cooling fluid (not shown) enters fluid channels 41 (e.g., such as formedby adhesive bonding, via adhesive 42, of fluid distribution membrane 32and substrate 31) under positive gage pressure of, for example, about 5to 20 PSI through fluid inlet tube 35 and fluid inlet fitting 34.Cooling fluid exits fluid channels 41 through fluid jets 39 into fluidcirculation chamber 44 (e.g., formed between fluid distribution membrane32 and heat transfer membrane 33) substantially perpendicular to theheat transfer membrane 33. The fluid is maintained at a predeterminedgage pressure between approximately 0.2 and 5 PSI by outlet pressurerelief valve 37, not shown. Since cooling fluid pressure within fluidchannels 41 is at a higher pressure than cooling fluid pressure withinfluid circulation chamber 44, cooling fluid from the jets is acceleratedby the difference in pressure. The jets of fluid 40 are directed at theinner surface of heat transfer membrane 33 and create fluid turbulenceat the inner surface of heat transfer membrane 33 (e.g., providing arelatively high Reynolds number at the surface of the heat transfermembrane while maintaining a low and positive fluid gage pressure withinthe fluid chamber). Such turbulence increases the heat transfer from thepatient's body, across heat transfer membrane 33, and into cooling fluidcontained in fluid circulation chamber 44.

The amount of fluid turbulence at the inner surface of heat transfermembrane 33 is a function of the fluid pressure differential betweenpressure in fluid channels 41 and the pressure in fluid circulationchamber 44 and the number and spacing of fluid jets 39, and the size offluid jets 39. A pressure differential of between approximately 5 and 15PSI with a fluid jet 39 spacing of between approximately 0.25 and 0.5inches in a 2 dimensional grid, and a fluid jet 39 diameter betweenapproximately 0.10 and 0.040 inches will provide sufficient turbulenceat the inner surface of heat transfer membrane 33 to effect efficientheat transfer.

Substrate 31, fluid distribution membrane 32, heat transfer membrane 33,fluid inlet fitting 34, and fluid outlet fitting (not shown) may bemolded from silicone rubber by conventional processes and may beassembled as shown using silicone adhesive 42. In one arrangement, theheat transfer membrane 33 has a thickness between approximately 0.001and 0.015 inches. In one arrangement, the fluid distribution membranehas a thickness between approximately 0.06 and 0.18 inches. The fluidinlet tube 35 and fluid outlet tube, in one arrangement, have an innerdiameter between approximately 0.12 and 0.38 inches, and may be made ofan elastomer material, such as silicone rubber, or a thermoplasticmaterial such as nylon, vinyl, or polycarbonate. Fluid inlet tube 35 andfluid outlet tube 38 can be insulated with foam rubber, for example.Fluid inlet tube 35 and fluid outlet tube 38 may be integrated into asingle assembly to form an umbilical.

FIG. 7A depicts a side view of an unpressurized body-surface coolingmodule 30. FIG. 7B depicts in sectional view between heat transfermembrane 33 and fluid distribution manifold 32 showing the surface offluid distribution manifold 32 and the distribution of fluid jets 39,and fluid outlet port 45. Fluid jets 39 are arranged in a substantiallyeven distribution about the face of fluid distribution membrane 32, asshown. Fluid outlet port 45 provides fluid communication from fluidcirculation chamber 44 (see FIG. 6) to fluid outlet pressure reliefvalve 37, fluid outlet fitting 36, and fluid outlet tube 38.

FIG. 8A depicts a side view of a generic body-surface cooling module 30un-pressurized. FIG. 8B depicts in sectional view of genericbody-surface cooling module 30 showing fluid manifold 43 of fluiddistribution membrane 32 comprising multiple fluid channels 41, andfluid inlet port 46. The fluid manifold 43 distributes cooling fluid tothe fluid jets 39 (see FIG. 7B). Fluid inlet port 46 communicatescooling fluid from fluid inlet tube 35 and fluid inlet fitting 34 tofluid manifold 43.

FIG. 9A depicts a side view of the body-cooling device 6 configured as aneck-cooling device 90. FIG. 9B depicts a top view of the neck-coolingdevice 90. Neck-cooling device 90 has a collar 47 (equivalent tosubstrate 31 in FIGS. 5, 6, 7 & 8), a first body-surface cooling module30-1, and a second body-surface cooling module 30-2. For theneck-cooling device 90, each body-surface cooling module 30-1, 30-2 isapproximately 3.5 inches high, approximately 2 inches wide, andapproximately 0.12 inches thick. The two body-surface cooling modules 30are spaced approximately 1.5 inches apart centered on either side of thechin cutout 48.

In one arrangement, the first body-surface cooling module 30-1 isconfigured to cover a first neck portion (e.g., constructed to cool thesurface of the neck of the patient in the vicinity of the left carotidartery and the left jugular vein) and the second body-surface coolingmodule 30-2 is configured to cover a second neck portion (e.g.,constructed to cool the surface of the neck of the patient in thevicinity of the right carotid artery and the right jugular vein). Insuch an arrangement, the neck-cooling device effectively cools the bloodflowing through the carotid arteries and jugular veins withoutsubstantially cooling the major muscles in the back of the neck therebyminimizing muscle spasm that result from substantial cooling of themajor muscles of the neck.

To apply to the neck-cooling device 90 to the patient, in onearrangement, the cooling modules are placed over the throat of thepatient with each cooling module positioned on either side of the AdamsApple. The collar is then fastened behind the neck with the Velcro looppad 50, and Velcro hook pad 49. Fluid inlet tubes 35 from each modulemay be joined by a “tee” fitting or integrally formed manifold into asingle conduit. Fluid outlet tubes 38 from each module may be joined bya tee fitting or integrally formed manifold into a single conduit. Fluidinlet and fluid outlet conduits may then be assembled into a singleumbilical.

FIG. 10A depicts a side view of an arrangement of body-surface coolingappliance 51 having multiple (4 in this example) body-surface coolingmodules 30. FIG. 10B depicts a front view of body-surface coolingappliance 51. FIG. 10C depicts a second side view of body-surfacecooling appliance 51.

In one arrangement, the body-surface cooling appliance 51 has substrate31, multiple module fluid distribution membrane 52, multiple module heattransfer membrane 53, four fluid inlet tubes 35, four fluid outlet tubes38, four fluid inlet fittings 34, four fluid outlet fittings 36containing four outlet pressure relief valves 37, and adhesive 42. Themultiple module fluid distribution membrane 52 is molded, for example,with four fluid manifolds 43, four fluid inlet ports 46, and four fluidoutlet ports 45 (see FIGS. 8A and 8B). Each fluid manifold 43, fluidinlet port 46, and fluid outlet port 45 are configured as a singlebody-surface cooling module in a four-quadrant arrangement as shown. Themultiple module heat transfer membrane 53 is sized to match the size ofmultiple module fluid distribution membrane 52, and is bonded tomultiple module fluid distribution membrane 52 using silicone adhesive42 in the pattern shown to form four separate fluid circulation chambers41 (see FIG. 6). Each individual cooling module has its own fluid inletand fluid outlet means previously described. Various body-surfacecooling appliances may be constructed using the multiple cooling moduleconstruction technique disclosed above including cooling blankets,cooling vests, cooling trousers, and cooling suits.

FIG. 11A depicts, in schematic form, an arrangement of the console 2.The console 2 has a case or housing 55, reservoir 56, battery 57, acontroller (e.g., such as a processor and memory) or mother board 58,negative gage pressure source (e.g., aspiration pump) 59, positive gagepressure source (e.g., fluid infusion pump) 60, fluid control valve 61,on/off switch 13, fluid tube connectors 78, 82, 83, & 84, temperaturesensor connector 64, aspiration pump outlet 65, and battery rechargerreceptacle 66.

In one arrangement, the console case 55 has a molded plastic structurethat mechanically integrates all system components described above intoa single small portable unit as shown. Console case includes carryinghandle 14, and feet 68. Carrying case 55 may be fabricated from moldedplastic, sheet metal, or a combination of molded plastic and sheetmetal. The console 2, in one arrangement is sized (e.g., has dimensions)and has a weight that provides portability to the console 2 and allows auser, such as an emergency medical technician, to transport the console2 to a patient at risk of ischemic injury (e.g., a patient with cardiacarrest, a patient with acute myocardial infarction, a patient with braintrauma, or a patient with stroke) and provide hypothermia therapy to thepatient prior to the patient's arrival at a hospital.

In one arrangement, the reservoir 56 is a sealable, insulatedcompartment within carrying case 55. In one arrangement, the reservoir56 is removable from the console 2. For example, the reservoir 56 has avolume of approximately two US gallons. Access door 69 including latch70, and water/air tight seal 71 provide a means for filling thereservoir 56 with cooling fluid (e.g., saline 72 and brine ice 73) priorto use, and draining the reservoir 56 once hypothermia therapy iscompleted. Access door 69 is closed thereby sealing reservoir 56 duringoperation of the system. Reservoir 56 includes fluid vacuum tube 74which provides a fluid conduit between the air space 77 at the top ofreservoir 56 and suction port 75 of aspiration pump 59, reservoiraspiration tube 76 provides a fluid conduit from the air space 77 at thetop of reservoir 56 to aspiration tube coupling 78, suction tube 79provides a fluid conduit from the bottom of reservoir 56 to low pressureport 80 of fluid infusion pump 60, and fluid return tube 81 whichprovides a fluid conduit between reservoir 56 and fluid outlet tubecoupling 82.

The negative gage pressure source (e.g., aspiration pump) 59, forexample, is a centrifugal air pump and pumps air from air space 77 inreservoir 56 out of carrying case 55 through air vent 65 as shownthereby causing a partial vacuum in air space 77. In one arrangement theaspiration channel 21 is in fluid communication, via aspiration tube 5,with the air space 77 having the vacuum. In such a configuration, thevacuum creates the negative gage pressure within the aspiration channel21.

The aspiration pump 59 has a power of approximately 1/20 to ⅓ of ahorsepower. In one arrangement the infusion pump 60 is a positivedisplacement liquid pump, such as a vane pump. Infusion pump 60 pumpssaline from reservoir 56 to fluid infusion tube coupling 83 throughfluid flow control valve 61 and to fluid inlet tube coupling 84 under apositive gage pressure between approximately 10 and 25 PSI. The pressureof the fluid supplied to fluid infusion tube coupling 83 and fluid inlettube coupling 84 can be controlled by adjusting the speed of the motorof infusion pump 60 by motherboard 58 or by a pressure relief/bypassvalve (not shown).

In one arrangement, the fluid flow control valve 60 controls the flow offluid from console 2 to head-cooling device 1 in an on/off manner. Fluidflow control valve 61 can be a solenoid actuated liquid valve. In onearrangement, motherboard (e.g., controller) 58 has electronic circuitsthat control the operation of all electrical components of the system byembedded hardware or software logic. A predetermined therapeutic bodytemperature can be embedded into the control logic of the motherboard58, or can be set by the user by a user control setting on the console 2(not shown). The motherboard 58 can also receive signals from othersystem sensors to provide safety interlocks, or to provide additionaltherapeutic functional controls. Temperature sensor connector 64provides a removable connection between body temperature sensor lead 11and console 1. Fluid couplings 78, 82, 83, and 84 include a receptaclemounted on carrying case 55, and a plug mounted on corresponding fluidtube. The receptacle and the plug of each coupling contain a valve suchthat when the plug and the receptacle are not coupled the valve in thereceptacle and the valve in the plugs close preventing fluid fromescaping from the console 1 through the receptacle, or from the fluidtube trough the plug. There are several lines of such valved couplingscommercially available. Battery 57 is rechargeable through an externalpower adapter (not shown) that may be connected to the console 2 byreceptacle 66.

In one arrangement, the cooling system 100 functions as described below.The head-cooling device 1, body-cooling device 6, and temperature sensor10 are placed on a patient. The fluid tubes 4, 5, 8, and 9 andtemperature sensor lead 11 are connected to console 2. The reservoir 56is filled with cooling fluid, such as approximately 10 pounds of brineice 73 and two quarts of saline 72 or equivalent amounts of ice andwater. Access door 69 is shut and sealed using latch mechanism 70. Theon/off switch 13 is positioned to the “on” position which causes themotherboard 58 to open fluid control valve 61 and activate aspirationpump 59 and fluid infusion pump 60. Aspiration pump 59 causes a partialvacuum in air space 77 resulting in a vacuum in aspiration channel 21 ofhead-cooling device 1 which therefore results in fluid return fromhead-cooling device to reservoir 56 as previously described.Simultaneously, fluid infusion pump 60 is supplying cold saline 72 tohead-cooling device 1 and body-cooling device 6 under pressure. Fluidreturns from the body-cooling device 6 to reservoir 56 passively bymeans shown.

Once the patient's body temperature reaches the predeterminedtemperature as sensed by body temperature sensor 10, motherboard 58closes fluid control valve 61 thereby stopping the flow of cold salineto head-cooling device 1 and the flow of cold saline is continued tobody-cooling device 6. Body temperature is maintained at predeterminedtemperature according to body temperature sensor 10 by modulating thespeed of the motor of infusion pump 60, or by modulating infusion pump60 “on” or “off” to control body temperature. Head-cooling device 1 maybe removed from the patient once the predetermined body temperature isreached. Ice is replenished in reservoir 56 as required. Console may beplugged into a wall outlet using an AC adapter (not shown) once thepatient reaches the hospital and run indefinitely. Once the therapy iscompleted the on/off switch 13 is moved to the “off” position, andbody-cooling device 6 and head-cooling device 1 is removed from thepatient.

During operation, the positive gage pressure source (e.g., fluidinfusion pump) 60 supplies cooling fluid from the cooling fluidreservoir 56 to the head-cooling device 1 under positive gage pressure.The negative gage pressure source (e.g., aspiration pump) 59 scavengescooling fluid from the head-cooling device 1 (e.g., via cooling fluidwicking through the patient's hair and into the aspiration channel 21).The controller 58 receives temperature signals from the body temperaturesensor (e.g., via the temperature sensor connector 64). Based upon thetemperature signals, the controller 58 (e.g., a temperature controlcircuit associated with the controller) adjusts the positive gagepressure source 60, negative gage pressure source 59, or the coolingfluid flow control valve 61 to increase or decrease the amount ofcooling fluid provided to the patient and thereby control cooling of thepatient.

FIG. 11B depicts another arrangement of the console 2 in schematic form.The console 2 has a housing or case 340 that has a cooling fluidreservoir 341, thermal battery 342, electrical battery 343, air pump344, water pump 345, on/off switch 346, pressure switch 347,head-cooling device aspiration tube receptacle 348, body-cooling devicefluid return tube receptacle 349, cooling cap fluid inlet tubereceptacle 350, body-cooling device fluid inlet tube receptacle 351, airvent 353, vacuum tube 354, aspiration tube 355, fluid tubes 356, 357,358, 359 and 360, wires 361, 362, 363, 364, 365, 366, and 367, and 369,and electrical contacts 37.

The reservoir 341 is air-tight and, in one arrangement, contains acooling fluid, such as saline 368, and air 369. The air pump 344, whenactivated, pumps air 369 from reservoir 341, through vacuum tube 354,out of case 340 trough air vent 353 which creates a pressure withinreservoir 341 below atmospheric pressure. The water pump 345, whenactivated, pumps saline 368 from reservoir 341, through thermal battery342, to head-cooling device 1 and body-cooling device 6 and back toreservoir 341 through aspiration tube 355, and fluid tube 356. Thermalbattery 342 removes heat from the saline 368 as the saline 368 traversesthrough the thermal battery 342, thereby lowering or reducing thetemperature of the saline 368 (e.g., cooling fluid). The electricalbattery 343 provides electrical power to air pump 344 and water pump345, and may be recharged by an external charging source throughelectrical contacts 307 mounted on the external surface of the consolecase 340.

In one arrangement, the air pump 344 aspirates the head-cooling device 1(e.g., the aspiration channel 21) and the water pump 345 supplies saline368 under pressure to the head-cooling device 1 and body-cooling device6. The thermal battery 342 is configured to cool the saline 368 duringoperation. The cooling cap aspiration tube receptacle 348 is mounted onconsole case 340, and provides removable connection of the cooling fluidaspiration tube 5 to the console 2. The body-cooling device fluid returntube receptacle 349 is coupled to the console case 340 and providesremovable connection of the cooling fluid outlet tube 9 to the console2. The cooling cap fluid inlet tube receptacle 350 is mounted on consolecase 340 and provides removable connection of cooling cap 1 a coolingfluid infusion tube 4 to console 2. The body-cooling device fluid tubereceptacle 351 is mounted on console case 340 and provides removableconnection of the cooling fluid inlet tube 8 to console 2. Receptacles348, 349, 350 and 351 provide a valve mechanism where when a respectivetube is connected to receptacle, fluid communication is provided betweenthe tube and the receptacle, and where if a tube is not connected to thereceptacle, a valve within the receptacle closes and prevents fluidcommunication outside of console 2.

Fluid tube 355 provides fluid communication between cooling capaspiration tube receptacle 348 and reservoir 341, as shown. Fluid tube356 provides fluid communication between cooling collar fluid returntube receptacle 349 and reservoir 341 as shown. Fluid tube 357 providesfluid communication between reservoir 341 and water pump 345 as shown.Fluid tube 358 provides fluid communication between water pump 345 andthermal battery 342 as shown. Bifurcated fluid tube 359 provides fluidcommunication between thermal battery 342 and cooling cap fluid inlettube receptacle 50 and cooling collar fluid inlet tube receptacle 51 asshown. Wire 361 connects the negative terminal of electrical battery 343to a first recharging contact 307. Wire 362 connects positive terminalof electrical battery 343 to a second recharging contact 307. Wire 63connects positive terminal of battery 343 to one terminal of on/offswitch 346. Wire 364 connects the second terminal of on/off switch 346to positive terminal of air pump 344. Wire 365 connects positiveterminal of air pump 344 to one terminal of pressure switch 347. Wire366 connects second terminal of pressure switch 347 to positive terminalof water pump 345. Wire 367 connects negative terminal of water pump 345to negative terminal of battery 343. Wire 370 connects negative terminalof air pump 344 to negative terminal of water pump 345.

During operation of the body cooling system 100 using the console 2 ofFIG. 11B, a user fits a head-cooling device 1 and a body cooling device6 is fitted to a patient. The user connects the umbillicals 3,7 of thehead-cooling device 1 and body-cooling cooling to receptacles 348, 349,350 and 351. The user places the on/off switch 346 into the “on”position to activate the air pump 44. The pressure switch 347 moves fromthe normally open position to the closed position and activates waterpump 345 once pressure within reservoir 341 is reduced by operation ofair pump 344 to a preset pressure of between approximately 1 to 10 PSIbelow atmospheric pressure. If pressure within reservoir 341 rises abovethe preset pressure stated above, pressure switch 347 moves from theclosed position to the normally open position and deactivates water pump45. The user moves the on/off switch 346 to the off position oncehypothermia therapy is concluded and removes the cooling cap 1 and bodycooling device 8 from the patient.

FIG. 11C depicts an arrangement of the thermal battery 342 of FIG. 11B.The thermal battery 342 has a housing 372, heat exchanger 371 having aheat exchanger tube 375 and, optionally, heat exchanger fins 374, afluid inlet fitting 376, a fluid outlet fitting 377, cooling medium 373,and a handle 378. The housing 372 contains heat exchanger 371 andcooling medium 373 and, in one arrangement, is molded from a polymersuch as high-density polyethylene. Cooling medium 373, in onearrangement, is a liquid solution or water having the property offreezing and melting at a constant temperature. Heat exchanger 371consists of a length of heat exchanger tube 375 which provides a fluidpath for saline 368 internal to housing 732 where heat exchanger tube375 is surrounded by and in thermal contact with cooling medium 373. Inone arrangement, the heat exchanger tube 375 is constructed fromstainless steel tubing having an inner diameter between approximately0.25 inches and 0.5 inches and a wall thickness between approximately0.005 and 0.020 inches. The shape heat exchanger tube 375 may beserpentine as shown or some other shape. The straight-line length ofheat exchanger tube 375 is between 12 inches and 120 inches. Metal heatexchanger fins 374 may be bonded to heat exchanger tube 375 to enhanceheat transfer from cooling medium 373 to saline 368 as it passes throughheat exchanger tube 375. Housing 372 is constructed so that thermalbattery 342 functions as a cassette and may be placed into, and removedfrom console 2. Console 2 is designed to receive thermal battery 342 asa cassette and is configured to provide easy user access to thermalbattery 342 and is configured to provide thermal insulation to thermalbattery 342 to prevent absorption of ambient heat. Fluid inlet fitting376, and fluid outlet fitting 377, provide fluid connection to console 2and mate with receptacles in console 2. Handle 378 facilitates placementand removal of thermal battery 342 from console 2.

In one arrangement, a user charges the thermal battery 342 by placingthe thermal battery 342 into a freezer for a period of time sufficientto convert cooling medium 373 from a liquid state to a solid state.Cooling medium 373 reverts back to a liquid state during use in patientcooling by absorbing heat from the patients body as transferred to thethermal battery 342 by circulation of saline 368 as previouslydescribed. In one arrangement, the cooling medium 373 is formulated tofreeze and melt at a temperature between approximately −15 and +10degrees centigrade. Cooling medium 373, for example, is a solution ofsalt water, a solution of water and another substance, or is water. Inone arrangement, the thermal battery 342 contains between 1 and 10pounds of cooling medium 373, and provides for patient cooling for aduration of between approximately 15 and 240 minutes.

FIG. 11D depicts an arrangement of the reservoir 341 of FIG. 11B. Thereservoir 341 has a housing 79, containing saline 368 and air 369, fluidoutlet pipe 380, fluid return pipe 381, aspiration pipe 382, vacuum pipe383, cage 384, ball 385, fluid outlet pipe fitting 386, fluid returnpipe fitting 387, aspiration pipe fitting 388, and vacuum pipe fitting389. Housing 379 is molded from a suitable polymer, such as high-densitypolyethylene, and has a fluid capacity of 1 to 4 liters. Fluid outletpipe 380 and fluid outlet pipe fitting 386 provides connection to thelow-pressure side of water pump 345 and is analogous to fluid tube 357.Fluid return pipe 381 and fluid return pipe fitting 387 provideconnection to cooling collar fluid return tube receptacle 349 and isanalogous to fluid tube 356. Aspiration pipe 382 and aspiration pipefitting 388 provides connection to cooling cap aspiration tubereceptacle 348 and is analogous to fluid tube 355. Vacuum pipe 383 andvacuum pipe fitting 389 provide connection to the low pressure side ofair pump 44 and is analogous to vacuum tube 354. Ball 384 is buoyant inwater and is held in close proximity of the internal end of vacuum pipe383 by cage 385. Ball 384 and cage 385 function as a valve to preventany saline from being drawn into vacuum tube 383 in the event thereservoir 341 does not remain upright as shown. Housing 379 isconstructed so that reservoir 341 functions as a cassette and may beplaced into, and removed from console 2. Console 2 is designed toreceive reservoir 341 as a cassette and is configured to provide easyuser access to reservoir 341, and is configured to provide thermalinsulation to reservoir 41 prevent absorption of ambient heat.Connection of the reservoir 341 to apparatus contained in console 2 asdescribed above is provided by a receptacle (not shown) that is integralwith console 2.

FIG. 12 depicts another arrangement of the head-cooling device 1 (e.g.,tissue cooling device). Head-cooling device 1 includes a tissue coveringportion or head cap 15, chinstrap 12, cooling fluid infusion tube 4,infusion manifold 16, air manifold 17, and air tube 5. Head cap 15 maybe either a rigid structure molded from thermoplastic such as nylon,vinyl, or polycarbonate, or may be a flexible structure molded from anelastomer such as silicone rubber. Chinstrap 12 holds head-coolingdevice 1 to the patient's head 29.

Cooling fluid enters head-cooling device 1 through cooling fluidinfusion tube 4 and infusion manifold 16 under positive gage pressurebetween approximately 0.2 and 40 PSI. Cooling fluid exits head-coolingdevice 1 by a fluid outlet 130 in communication with the cap 15 and influid communication with the fluid circulation space 25. For example, inone arrangement, the fluid outlet 130 includes a fluid return manifold134 and a cooling fluid return tube 132. The fluid outlet 130 isconfigured to allow egress of the cooling fluid from the fluidcirculation space 25. For example, in one arrangement, the fluid outlet130 allows the cooling fluid to exit the fluid circulation space 25under a positive gage pressure between approximately 0.2 and 2 PSI. Acheck valve 136 (e.g., as illustrated in FIG. 13) forms part of thefluid return manifold 134 and operates to maintain a positive gagepressure within head-cooling device 1 (e.g., within the fluidcirculation space 25) so that a siphoning effect, and resulting negativegage pressure within head-cooling device 1 is prevented.

FIG. 13 depicts, in sectional view, the construction of head cap 15 ofhead-cooling device 1. Head cap 15 has inner wall 19, outer wall 24,fluid channels 18 formed between inner wall 19 and outer wall 24, fluidjets 20 formed in inner wall 19 over fluid channels 18, channel 21formed by inner seal 22 and outer seal 23 and outer wall 24. Infusionmanifold 16 is bonded to head cap 15 or may be integrally molded intohead cap 15. Infusion manifold 16 provides fluid communication betweencooling fluid infusion tube 4 and fluid channels 18. Fluid returnmanifold 134 is bonded to head cap 15 or may be integrally molded intohead cap 15. Fluid return manifold 134 provides fluid communicationbetween cooling fluid return tube 132 and fluid circulation space 25(see FIG. 14). Air manifold 17 is bonded to head cap 15 or may beintegrally molded into head cap 15. Air manifold 17 provides fluidcommunication between air tube 5 and channel 21 (see FIGS. 13 & 14).

FIG. 14 depicts in sectional view the head-cooling device mounted on thehead of a patient showing the cooling fluid circulation space 25, airspace 26, and the functional relationship between the cooling fluidcirculation space 25 and the air space 26. Cooling fluid circulationspace 25 includes the volumetric space between inner wall 19, patient'sscalp 28, and inner seal 22, and includes the volumetric space occupiedby the patient's hair 27 within the just defined cooling fluidcirculation space 25. The air space 26 includes the volumetric spacebetween the patient's scalp 28 and channel 21 comprising inner seal 22,outer seal 23 and outer wall 24, and is maintained at a higher gagepressure than fluid in circulation space 25. Channel 21 is molded froman elastomer material such as silicone rubber.

In one arrangement, during operation, the air manifold 17 connects, viaair tube 5, to a positive gage pressure source that, in one arrangement,provides pressurized air to the channel 21. The pressure within thechannel 21 is greater than the pressure within the fluid circulationspace 25, thereby sealing the rim 110 of the cap 15 to the patient'shead. Inner seal 22 is configured by geometry and material selection toresist the flow of pressurized air from channel 21 through the hair 27into fluid circulation space 26 such that pressurized air in channel 21remains at a higher gage pressure than fluid in circulation space 25.Since air in channel 21 is at a higher gage pressure than fluid incirculation space 25, fluid in circulation space 25 is prevented fromexiting fluid circulation space 25 through inner seal 22. Outer seal 23is configured by geometry and material selection to resist the flow ofair through the hair 27 from inside channel 21 such that pressure withinaspiration channel is maintained at a positive gage pressure betweenapproximately 0.2 and 10 PSI by an air pressurization source (e.g.,positive gage pressure source) provided by console 2. Cooling fluid isscavenged from the head cap 15 through fluid return tube 132 providedthat the pressure within channel 21 remains at a positive gage pressuregreater than the gage pressure within fluid circulation space 25.

FIG. 15 depicts in schematic form, an arrangement of the portableconsole 2 for use with the cooling device illustrated in FIGS. 12-14.The portable console 2 has a housing or console case 55, reservoir 56,battery 57, mother board 58, compressor 59, fluid infusion pump 60,on/off switch 13, fluid tube connectors 178 and 183, air tube connector182, temperature sensor connector 64, and battery recharger receptacle66. Fluid couplings 178, 182, and 183 comprise a receptacle mounted oncarrying case 55, and a plug mounted on corresponding fluid tubes 132,5, and 4.

A vent (not shown) is provided within the reservoir so that reservoir 56remains at ambient pressure at all times. Suction tube 79 provides afluid conduit from the bottom of reservoir 56 to low pressure port 80 offluid infusion pump 60, and fluid return tube 81 which provides a fluidconduit between reservoir 56 and fluid return tube coupling 78.Compressor 59 may be a centrifugal air pump and pumps air under positivepressure to channel 21 (FIGS. 13 & 14). Compressor 59 has a power ofapproximately 1/20 to ⅓ of a horsepower. Infusion pump 60 is a positivedisplacement liquid pump, such as a vane pump.

During operation, the infusion pump 60 pumps a cooling fluid fromreservoir 56 to fluid inlet tube coupling 183 under a positive gagepressure between approximately 2 and 25 PSI. The pressure of the fluidsupplied to fluid infusion tube coupling 183 can be controlled byadjusting the speed of the motor of infusion pump 60 by motherboard 58or can be controlled by a pressure relief/bypass valve (not shown). Apositive gage pressure pump 80, such as an air pump, provides air to thechannel 21 via connector 183 and tube 4 to pressurize the channel 21 andseal the cap 15 to the patient's head. Also during operation, fluidreturns to the console 2 from the fluid circulation space 25, defined bythe head-cooling device 1, via the fluid return tube 132. For example,in one arrangement, the cooling fluid exits the head-cooling device 1when the pressure within the fluid circulation space 25 causes the valve136 within the fluid return manifold 134 to open. In anotherarrangement, the fluid exits the head-cooling device 1 and returns tothe console 2 via gravity (e.g., a gravity feed system).

Returning to FIGS. 12-14, in one arrangement, during operation, the airmanifold 17 connects, via air tube 5, to a negative gage pressure sourcethat removes air from the channel 21. During operation, the pressurewithin the channel 21 (e.g., aspiration channel) is less than thepressure within the fluid circulation space 25, thereby sealing the rim110 of the cap 15 to the patient's head. Such sealing maintains thecooling fluid within the fluid circulation space 25 and minimizesleakage of the fluid past the rim 110 of the cap 15. In such aconfiguration, cooling fluid exits the head cap 15 through fluid outlet130 and fluid return tube 132.

FIG. 16 illustrates an arrangement of the head-cooling device 1illustrated in FIGS. 12-14. The head-cooling device 1 has head supportsor protrusions 138 disposed on the inner surface 102 of the cap 15. Theprotrusions 138 are configured to contact the back of a patient's headto separate the patient's head from a back portion 174 of thehead-cooling device 1. The head supports 138, therefore, define a fluidcollection reservoir 140 in fluid communication with the fluidcirculation space 25. During operation, in one arrangement, the fluidcollection reservoir 140 acts as a sink for cooling fluid pumped intothe fluid circulation space 25 and directs the cooling fluid to thesecond fluid outlet 130. In one arrangement, the cooling fluid exits thefluid collection reservoir 140, via the second fluid outlet 130, under apositive gage pressure. In another arrangement, the second fluid outlet130 is open to the atmosphere, thereby allowing removal of the coolingfluid from the fluid collection reservoir 140 via gravity (e.g., agravity feed).

FIG. 17 illustrates one arrangement of the head-cooling device 1 wherethe cap 15 is formed of a flexible material and includes a substantiallyrigid shell 150 coupled to the outer surface 104 of the cap 15. Forexample, the rigid shell 150 is formed of a polyethylene (PET) plasticmaterial. During operation the positive gage pressure source of theconsole 2 provides cooling fluid to the head-cooling device 1 and aidsin maintaining the pressure within the fluid circulation space 25between approximately 0.1 and 10 PSI. Also during operation, thenegative gage pressure source of the console 2 removes air from withinthe aspiration channel 21 and maintains the pressure within theaspiration channel 21 between approximately −0.1 and −10 PSI. In certaincases, the pressure within the fluid circulation space 25 causes the cap15 (e.g. the portion of the cap 15 defining the fluid circulation space25) to expand or “balloon” relative to a head 148 of the patient. Therigid shell 150 minimizes expansion of the cap 15 during operation,thereby limiting the potential for the fluid circulation space 25 tobreak the seal formed by the aspiration channel 21 and cause fluid toleak from the cap 15.

FIG. 18 illustrates an arrangement of the head-cooling device 1 wherethe fluid inlet 112 and the fluid outlet 114 of the head-cooling device1 are configured to include swivel joints 152. For example, the fluidinlet 112 includes inlet swivel joint 152-1 and the fluid outlet 114includes outlet swivel joint 152-2. The inlet swivel joint 152-1 allowsrotation 154 of the inlet connector 158 (e.g., connected to therespective cooling fluid infusion tube 4) relative to an axis 156-1substantially perpendicular to the outer surface 104 of the head-coolingdevice 1. The outlet swivel joint 152-2 allows rotation 154 of theoutlet connector 160 (e.g., connected to the respective cooling fluidaspiration tube 5) relative to an axis 156-2 substantially perpendicularto the outer surface 104 of the cap 15. The swivel joints 152-1, 152-2allow positioning of the head-cooling device 1 at various locations ororientations relative to the console 2 while minimizing strain on, orbending and kinking of, the tubes 4, 5. For example, when a userpositions the head-cooling device 1 relative to the console 2, theswivel joints 152 allow the connectors 158, 160 and associated tubes 4,5 to rotate relative to the head-cooling device 1.

FIG. 19 illustrates an arrangement of the head-cooling device 1 wherethe cap 15 has handles 166 integrally formed with the cap 15. In onearrangement, the cap 15 has a first handle 166-1 oriented on a firstside 168 of the head-cooling device 1 and a second handle (not shown)oriented on a second side of the head-cooling device 1 (e.g., opposingthe first side 168 of the head-cooling device 1). The handles 166 allowa user (e.g., an emergency medical technician) to grasp the head-coolingdevice 1 and position the head-cooling device 1 onto a patient's head148. For example, assume the cooling device is formed from a flexiblematerial. During installation, the user inserts his thumbs within thehandles 166 and places a front portion 170 of the head-cooling device 1in contact with a forehead of a patient's head 148. Using the handles166, the user applies a force in a first direction 172, substantiallyperpendicular to the front portion 170 of the head-cooling device 1. Theuser then uses the handles 166 to apply a force in a second direction174 (e.g., substantially perpendicular to the force applied in the firstdirection 172) to place a back portion 174 of the head-cooling device 1in contact with a back of the patient's head 148.

FIG. 20 illustrates one arrangement of the head-cooling device 1 wherethe cap 15 is configured such that the fluid inlet 112 is located inproximity to the fluid outlet 114. For example, as shown, both the fluidinlet 112 and the fluid outlet 114 are oriented on a top portion 180 ofthe cap 15. Such a configuration allows use of a single umbilical 3having both the cooling fluid infusion tube 4 and the cooling fluidaspiration tube 5 with associated connectors 158, 160. Such aconfiguration minimizes the need for separate tubes 4, 5 (e.g., attachedto the cap 15 in non-proximal locations) to attach the head-coolingdevice 1 to the console 2, thereby minimizing the amount of timerequired by the user to initiate hypothermia treatment to a patient atrisk for ischemic injury, for example.

FIGS. 21 and 22 illustrate an arrangement of the head-cooling device 1where the head-cooling device 1 has a movement stabilizer component 184located on the outer surface 104 of the cap 15. For example, themovement stabilizer component 184 is integrally formed along a backportion 174 of the cap 15. In one arrangement, the movement stabilizercomponent 184 has a first stabilizer portion 186 and a second stabilizerportion 188. During operation, after a user places the head-coolingdevice 1 on the head 148 of a patient, the user places the patient'shead 148 onto a resting surface, such as a bed or a table. The firststabilizer portion 186 and the second stabilizer portion 188 of themovement stabilizer component 184 contact the resting surface andminimize rotation of the head 148 during hypothermia treatment. As shownin FIG. 22, the first stabilizer portion 186 and the second stabilizerportion 188 of the movement stabilizer component 184 also providegripping surfaces for the head-cooling device 1 to allow user adjustmentof the patient's head 148. For example, a user grasps the firststabilizer portion 186 and the second stabilizer portion 188 to rotate190 the head 148 relative to a resting surface to ensure adequatecontact (e.g., minimize gaps) between the movement stabilizer component184 and the resting surface to minimize inadvertent motion of thepatient's head during operation of the head-cooling device 1.

FIGS. 23 and 24 illustrate one arrangement of the head-cooling device 1where the cap 15 has a fluid distribution manifold 200 configured toremovably couple to the fluid inlet 112 of the cap 15. In onearrangement, the fluid distribution manifold 200 is formed from apolyethylene (PET) plastic material. The fluid distribution manifold 200has a connector portion 202, arms 204 defining jets 20, and attachmentmechanisms 206 associated with each arm 204. Use of the removable fluiddistribution manifold 200 allows a user to replace the fluiddistribution manifold 200 in the case where the jets 20 become cloggedor degrade after repeated use of the head-cooling device 1.

The connector portion 202, in one arrangement, is configured to insertwithin the fluid inlet 112 of the cap 15, via a friction or interferencefit, to secure a first end 212 of the fluid distribution manifold 200 tothe cap 15. The connector portion 202 receives cooling fluid from thecooling fluid source (e.g., reservoir of the console 2) and allows flowof the fluid within the arms 204 of the fluid distribution manifold 200.The attachment mechanisms 206 associated with each arm 204 areconfigured to insert within the first sealing member 22 of the channel21 in one arrangement. The attachment mechanisms 206 secure a second end216 of the fluid distribution manifold 200 to the cap 15.

FIG. 25 illustrates a cross-sectional view of an arm 204 of the fluiddistribution manifold 200. Each arm 204 defines openings or jets 20 usedto distribute cooling fluid, from the fluid source, to the fluidcirculation space 25. Cooling fluid travels from the connector portion202 through the arms 204 via a channel 218 defined by the arms 204. Thecooling fluid exits the fluid distribution manifold 200 via the openings20.

FIG. 23 also illustrates the use of ventilation openings 220 within thecap 15. In one arrangement, the first sealing member 22 definesventilation openings 220 oriented between the aspiration channel 21 andthe fluid circulation space 25. During operation, the aspiration channel21 attaches to a negative gage pressure source. The negative gagepressure source removes air from the aspiration channel 21 to seal therim of the cap 15 to a patient's head. During operation, however, aircan enter the fluid circulation space 25 and reduce the volume, andtherefore the efficiency, of the cooling fluid within the fluidcirculation space 25. The ventilation openings 220 provide fluidcommunication between the aspiration channel 21 and the fluidcirculation space 25 such that, during operation, the aspiration channel21 scavenges or removes air within the circulation space 25, therebymaximizing the amount of cooling fluid within the fluid circulationspace 25. In one arrangement, the first sealing member 22 defines theventilation openings 220 along a front portion 170 of the cap 15, suchthat the first sealing member 22 defining the ventilation openings 220contacts a forehead of a patient's head.

FIGS. 26 and 27 illustrate one arrangement of the head-cooling device 1where the channel 21 has a third sealing member 226 disposed on theinner surface 102 of the cap 15 about a circumference defined by the cap15. The third sealing member 226 orients between the first sealingmember 22 and the second sealing member 23 of the channel 21. The thirdsealing member 226 divides the channel 21 into a first channel portion21-1 and a second channel portion 21-2. As illustrated in FIG. 27, boththe first channel portion 21-1 and the second channel portion 21-2 arein fluid communication with the aspiration manifold 17 of the cap 15.When a patient wears the head-cooling device 1, the first sealing member22, the second sealing member 23, and the third sealing member 226contact the patient's head. During operation, a negative gage pressuresource removes air from the first channel portion 21-1 and the secondchannel portion 21-2 to seal the cap 15 against the patient's head 148.Because the third sealing member 226 divides the channel 21 intoseparate sealing portions 21-1, 21-2, the third sealing member 226creates a secondary seal (e.g., second channel portion 21-2) between thepatient's head 148 and the head-cooling device 1 during operation. Sucha secondary seal minimizes cooling fluid (e.g., cooling fluid thatmigrates into the channel 21) from flowing beyond the rim 110 of thehead-cooling device 1 during operation.

FIG. 28 illustrates one arrangement of the head-cooling device 1 wherethe aspiration channel 21 includes a fluid absorption material 230. Forexample, the absorption material 230 is formed of a sponge or foam-typematerial having fluid absorbance properties. In one arrangement, theaspiration channel 21 attaches to a negative gage pressure source andactively removes fluid from the fluid circulation space 25. In such anarrangement, the absorption material 230 aids in directing the fluidfrom the fluid circulation space 25 into the aspiration channel 21 andmaintaining the fluid within the aspiration channel 21 (e.g., minimizesleakage of the fluid). In another arrangement, the aspiration channel 21is open to the atmosphere (e.g., does not attach to a negative gagepressure source). In such an arrangement, the absorption material 230aids in directing the cooling fluid from the fluid circulation space 25into the aspiration channel 21. For example, assume the aspirationchannel 21 has an outlet port open to the atmosphere and located at arear or back portion 174 of the cap 15. The absorption material 230absorbs cooling fluid from the fluid circulation space, such as viawicking through the patient's hair, and carries the cooling fluid to theoutlet port. Because the outlet port is open to the atmosphere, thecooling fluid exits the aspiration channel by way of gravity (e.g., agravity feed).

FIGS. 29 and 30 illustrate one arrangement of the head-cooling device 1where the cap 15 defines flow channels 234 disposed on the inner surface102 of the cap 15 and in fluid communication with the fluid circulationspace 25. In one arrangement, the flow channels 234 are formed asprotrusions extending from the inner surface 102 of the cap 15. Duringoperation, cooling fluid enters the cap 15 via an inlet (e.g., inletmanifold 16) and flows 236 across the flow channels 234 within the cap15. The flow channels 234 distribute the cooling fluid to a patient'shead in a substantially uniform manner, as indicated in FIG. 30. Suchdistribution minimizes non-uniform cooling of the patient's head andminimized the amount of time required to induce systemic hypothermia inthe patient.

FIG. 31 illustrates a fluid collection reservoir 240 for use with thehead-cooling device 1. The fluid collection reservoir 240 definescollection chambers 244, such as a first collection chamber 244-1 and asecond collection chamber 244-2, vent 242 and a suction channel thatattaches to the aspiration channel 21 of the cap 15. In one arrangement,the fluid collection reservoir 240 couples to a rear or back portion 174of the cap 15 such that the fluid collection reservoir 240 is in fluidcommunication with both the fluid circulation space 25 and theaspiration channel 21 of the cap 15.

For example, during operation, cooling fluid enters the cooling devicevia an inlet (e.g., inlet manifold 16). The cooling fluid circulateswithin the fluid circulation space 25, defined by the cap 15. Becausethe vent 242 of the fluid collection reservoir 240 is open to theatmosphere, the vent 242 causes the cooling fluid to collect within thechambers 244-1, 244-2 of the fluid collection reservoir 240. The suctionchannel 21 of the fluid collection reservoir 240 attaches to theaspiration channel 21 of the cap 15 that, in turn, attaches to anegative gage pressure source. Suction created by the negative gagepressure source causes the fluid, collected within the chambers 244-1,244-2 to flow 246 into the suction channel 21, via a Venturi effect. Theassociated aspiration channel 21 returns the cooling fluid to theconsole 2 for recooling.

FIGS. 32 and 33 illustrate an arrangement of the head-cooling device 1.The head-cooling device 1 has an aspiration channel 21 having anaspiration channel outlet 252, such as an aspiration manifold 17, fluidinlets 112, and a fluid outlet 114. The head-cooling device 1 defines avent opening 250 and defines a support 256 surrounding each of the fluidinlets 112, fluid outlet 114, and the vent opening 250. The supports256, in one arrangement, are hemispherically shaped and are configuredto maintain spacing between, and minimize blockage between, thepatient's head 29 and the fluid inlets 112, fluid outlet 114, and thevent opening 250.

The aspiration channel outlet 252 allows the head-cooling device 1 tomaintain the aspiration channel 21 (e.g., a volume between theaspiration channel 21 and the patient's head 29) at a negative gagepressure, thereby allowing removal of air from the aspiration channel 21and sealing the rim 110 of the cap 15 against the patient's head 29. Forexample, in one arrangement, the aspiration channel outlet 252 connectsto a negative gage pressure source within the console 2. Duringoperation, the negative gage pressure source induces a negative gagepressure within the channel 21 to seal the rim 110 of the cap 15 to thehead 29.

In one arrangement, the head-cooling device 1 has multiple fluid inlets112-1, 112-2, 112-N that provide substantially uniform distribution andflow of cooling fluid within the fluid circulation space 25 between thecap 15 and the patient's head 29. In one arrangement, each of the fluidinlets 112 has a respective nozzle 260 that provides a spray of coolingfluid to the patient's head 29. The nozzles 260 provide substantiallyuniform distribution of cooling fluid within the fluid circulation space25.

The vent opening 250, defined by the head-cooling device 1, in onearrangement, opens the fluid circulation space 25 to the atmosphere tosubstantially equalize the pressure within the fluid circulation space25 to atmospheric pressure. In such an arrangement, the vent opening 250maintains the fluid circulation space 25 at substantially atmosphericpressure. In one arrangement, the vent opening 250 has a check valve254. The check valve 254 minimizes the ability of the cooling fluid toexit the fluid circulation space 25 through the vent opening 250,thereby minimizing leakage of the cooling fluid from the head-coolingdevice 1, and maintains communication between the fluid circulationspace 25 and the atmosphere. The fluid outlet 114 is open to theatmosphere and oriented at a back portion 174 of the head-cooling device1. In such a configuration, with the fluid circulation space 25maintained at atmospheric pressure (e.g., via the vent opening 250), thefluid outlet 114 allows cooling fluid to exit the fluid circulationspace 25 via gravity (e.g., a gravity feed).

FIG. 34 illustrates an arrangement of the umbilical 3 connecting thehead-cooling device 1 to a console 2. The umbilical 3 has an inlet tube262 attached to an inlet tube connector 264, an outlet tube 266 attachedto an outlet tube connector 268.

The inlet tube 262 couples the fluid inlets 112 of the head-coolingdevice 1 to a positive gage pressure source of the console 2. The outlettube 266 couples the aspiration channel 21 of the head-cooling device 1to a negative gage pressure source of the console 2. In one arrangement,the outlet tube 266 is configured as a first outlet tube 266-1 and asecond outlet tube 266-2 where the first outlet tube 266-1 couples theaspiration channel 21 of the head-cooling device 1 to the negative gagepressure source of the console 2 and the second outlet tube 266-2couples the fluid outlet 114 of the head-cooling device to the negativegage pressure source of the console 2. In one arrangement, a thermallyinsulated conduit 274 surrounds both the inlet tube 262 and the outlettube 266. The thermally insulated conduit 274 minimizes heating of thecooling fluid carried by the tubes 262, 266 to or from the head-coolingdevice 1.

In one arrangement, the inlet tube 262 has an inlet tube check valve270-1 located between the head-cooling device 1 and the console 2 whilethe outlet tube 270 has an outlet tube check valve 270-2 located betweenthe head-cooling device 1 and the console 2. The inlet check valve 270-1and the outlet check valve 270-2 minimize leakage of cooling fluid fromthe umbilical 3 when a user removes the head-cooling device 1 from thepatient's head 29 (e.g., after application of the cooling fluid to thepatient is completed).

In one arrangement, the outlet tube 270 has a debris collector 272, suchas a screen, located between the head-cooling device 1 and the console2. For example, during operation, hair from the patient's head can enterthe outlet tube 270 and travel to the console 2, thereby potentiallyclogging and damaging the pumps (e.g., positive gage pressure source andnegative gage pressure source) associated with the console 2. The debriscollector 272 minimizes the amount of material (e.g., hair) received bythe console 2 from the head-cooling device 1 during operation.

FIG. 35 illustrates an arrangement of the console 2, such as for usewith the head-cooling device 1 as shown in FIGS. 32-34. The console 2has flow connectors 276, a body temperature sensor connector 278, and acomputerized device connector 280. The console 2 also has a pressurerelease valve 282, a first flow switch 283, a second flow switch 284, apositive gage pressure source (e.g., first pump) 285, a negative gagepressure source (e.g., second pump) 286, a reservoir level sensor 288,and a cooling fluid temperature sensor 290. The controller also has thereservoir 56, controller 58, battery 57, a power supply 293 inelectrical communication with the controller 58 and in electricalcommunication with a power connector 294. The power connector 294, inone arrangement, is configured to provide power to the power supply 293from a power source 295, such as a wall outlet.

The flow connectors 276, in one arrangement, include a first flowconnector 276-1 and a second flow connector 276-2. The first flowconnector 276-1 allows connection of the aspiration channel outlet 252of the head-cooling device 1 to the negative gage pressure source 286 ofthe console 2. The second flow connector 276-2 allows connection of thefluid inlet 112 of the head-cooling device 1 to the positive gagepressure source 285 of the console 2. The computerized device connector280 allows connection of a computerized device 296, such as a personalcomputer, to the controller 58, thereby allowing a user to retrieve andstore data (e.g., such as information collected by the sensor 10)collected by the controller 58 of the console 2.

The sensor connector 278 allows connection of a sensor, such as a bodytemperature sensor 10 to the controller (e.g., motherboard) 58 of theconsole 2. Such connection allows the controller 58 to display ameasurement (e.g., a body temperature measurement), as measured by thesensor, to a user via a display. In one arrangement, the controller 58uses a patient's body core temperature measurement, as measured andtransmitted by the temperature sensor 10, to control operation of thecooling system 100.

For example, in one arrangement, the patient's body core temperature hasa set-point range between approximately 32° C.-37° C. The controller 58is configured with a particular set-point value. During operation, thetemperature sensor 10 transmits a temperature signal (e.g., body coretemperature signal) to the controller. When the controller 58 detectsthe temperature signal is, for example, 0.2° C. greater than theset-point value, the controller 58 transmits a signal to the first pump285 and the second pump 286 that causes the pumps 285, 286 to circulatecooling fluid within the cooling system 100 (e.g., to and from thepatient). When the controller 58 detects the temperature signal is, forexample, 0.0° C. above the set-point value, the controller 58 transmitsa signal to the first pump 285 and the second pump 286 that causes thepumps 285, 286 to stop circulation of cooling fluid within the coolingsystem 100 (e.g., to and from the patient).

The first flow switch 283 is in fluid communication with the reservoir56 and in electrical communication with the controller 58. The firstflow switch 283 positions, within a fluid flow path, between thereservoir 56 and the fluid inlet 112 of the head-cooling device 1. Thesecond flow switch 284 is in fluid communication with the reservoir 56and in electrical communication with the controller 58. The second flowswitch 284 positions, within a fluid flow path, between the reservoir 56and the aspiration channel outlet 252 of the head-cooling device 1. Thefirst flow switch 283 and the second flow switch 284 are configured todetect flow along the respective flow paths. For example, in onearrangement, when the first flow switch 283 detects a reduction incooling fluid flow along the respective flow path (e.g., indicating ablockage along the flow path), the flow switches 283, 284 transmit asignal (e.g., flow warning signal) to the controller 58. In response tothe signal, the controller 58 indicates to a user, via a display,blockage of the flow path, thereby allowing the user to unblock the flowpath to ensure adequate operation of the cooling system 100.

The pressure release valve 282 positions, within a fluid flow path,between the flow switch 283 and the fluid inlet 112 of the head-coolingdevice 1. The pressure release valve 282 is configured to regulatepressure of the cooling fluid from the positive gage pressure source 285to the head-cooling device 1 (e.g., a fluid circulation space 25 definedbetween the head-cooling device 1 and a patient's head 29). For example,in the case where the fluid pressure within the fluid circulation space25 exceeds a preset maximum, the pressure regulation valve 282 directsthe cooling fluid from the positive gage pressure source 285 to thereservoir 56, thereby minimizing over pressurization and potentialfailure of the head-cooling device 1.

The level sensor 288, in one arrangement, is in fluid communication withthe cooling fluid within the reservoir 56 and is in electricalcommunication with the controller 58. The level sensor 288 is configuredto detect an amount of cooling fluid within the reservoir 56. Forexample, in one arrangement, when the level sensor 288 detects theamount of fluid within the reservoir 56 falls below a preset level, thelevel sensor 288 transmits a signal (e.g., level warning signal) to thecontroller 58. In response to the signal, the controller 58 indicates toa user, via a display, a low level of cooling fluid within the reservoir56, thereby allowing the user to fill the reservoir 56 with additionalcooling fluid to ensure adequate operation of the cooling system 100.

The temperature sensor 290, in one arrangement, is in fluidcommunication with the cooling fluid within the reservoir 56 and is inelectrical communication with the controller 58. The temperature sensor290 is configured to measure the temperature of the cooling fluid withinthe reservoir 56. For example, when the temperature sensor 290 detectsthe temperature of the cooling fluid rises above a preset level, thetemperature sensor 290 transmits a signal (e.g., temperature warningsignal) to the controller 58. In response to the signal, the controller58 indicates to a user, via a display, a relatively high temperature ofthe cooling fluid, thereby allowing the user to reduce the temperatureof the cooling fluid or replace the cooling fluid with relatively lowtemperature cooling fluid to ensure adequate operation of the coolingsystem 100.

In one arrangement, the reservoir 56 defines a substantially conicalshape. For example, the reservoir 56 is formed of a tapered wall suchthat the taper narrows toward a fluid outlet of the reservoir 56. Theconical shape of the reservoir 56 allows substantially complete drainageof the cooling fluid from the reservoir 56 after operation of thecooling system 100. In one arrangement, the reservoir 56 has a reservoirscreen 292 oriented in proximity to the reservoir outlet. The reservoirscreen 292 minimizes blockage of the reservoir outlet, such as caused byice or solid substances within the reservoir 56, during draining of thereservoir 56.

In one arrangement, the reservoir outlet has a valve 297 coupled to anexternal drain 298, such as a drain reservoir. The valve 297 minimizesleakage of the reservoir 56 during operation of the cooling system 100and allows drainage of the reservoir 56 into the external drain 298.

FIG. 36 illustrates a method 400 for inducing hypothermia in a body to apreset temperature. In one arrangement, a user, such as a medicaltechnician, performs the method 350.

In step 402, a user places a head-cooling device 1 on a head of a body.For example, the head-cooling device 1 allows contact between thepatient's head and a cooling fluid pumped into the head-cooling device 1to induce systemic hypothermia in the patient.

In step 404, the user places at least one body-cooling device 6 on asecond part of the body. For example, in the case where the body-coolingdevice 6 is configured as a neck-cooling device 90, the user places thedevice 90 onto the patient in the region of the left carotid artery andthe left jugular vein and in the region of the right carotid artery andthe right jugular vein. In such an arrangement, the neck-cooling device90 effectively cools the blood flowing through the carotid arteries andjugular veins and increases the rate of induction of systemichypothermia within the patient.

In step 406, the user cools the patient with the head-cooling device 1and the body-cooling device 6 until the body temperature of the patientreaches a preset temperature. For example, assume the user measures thecore body temperature of the patient using the body temperature sensor10. When the core body temperature reaches a preset level of betweenapproximately 32° C. and 37° C. the body temperature sensor 10 indicatesthe temperature to the user, thereby notifying the user that systemichypothermia has been achieved in the patient.

In step 408, the user discontinues the head cooling with thehead-cooling device 1 while continuing cooling of the second part of thebody with the body-cooling device 6 to maintain the patient's bodytemperature at the preset temperature. By removing the head-coolingdevice 1, the user minimizes the risk of lowering the temperature of thepatient below a low-level threshold (e.g., below approximately 32° C.),thereby potentially endangering the patient.

While this invention has been particularly shown and described withreferences to preferred embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the spirit and scope of theinvention as defined by the appended claims.

As described above, the cooling system 100 includes a console 2 and atissue cooling device. As indicated above, in one arrangement, thetissue cooling device is configured as the head-cooling device 1. Alsoas indicated above, the tissue cooling device is configured as thebody-cooling device 6 where the body-cooling device 6 has a heattransfer membrane 33. During operation, jets of fluid 40 are directed atthe inner surface of heat transfer membrane 33 and create fluidturbulence at the inner surface of heat transfer membrane 33. Duringoperation, (e.g., when the heat transfer membrane contacts a bodyportion or tissue region of interest of a patient), such turbulenceincreases the heat transfer from the patient's body, across heattransfer membrane 33, and into cooling fluid contained in fluidcirculation chamber 44. Such a configuration of the body-cooling device6 is by way of example only. In one arrangement, the body-cooling device6 is configured as having an aspiration channel oriented about an edgeof the body-cooling device 6.

For example, the body-cooling device 6 includes a tissue coveringportion (e.g., such as substrate 31) having an outer surface and aninner surface. The tissue covering portion defines an edge and isconfigured to cover a tissue region of interest. For example, in thecase where the body-cooling device 6 is a neck-cooling device 90, thebody-cooling device 6 covers the neck of the wearer. The body-coolingdevice 6 further includes an inlet in communication with the tissuecovering portion. The inlet receives pressurized fluid from a pressuresource (e.g., from the positive gage pressure source of the console 2)and distributes the cooling fluid to the tissue region of interest. Forexample, as the inlet distributes the cooling fluid to the tissue regionof interest (e.g., to the neck), the cooling fluid contacts the tissue(e.g., neck) covered by the tissue covering portion.

The body-cooling device 6 further includes an aspiration channeldisposed on the inner surface of the tissue covering portion about theedge defined by the tissue covering portion. For example, in onearrangement, the aspiration channel is configured as the aspirationchannel illustrated in FIG. 4 (e.g., is defined by a first sealingmember, a second sealing member, and a second inner surface of thetissue covering portion). The aspiration channel fluidly communicateswith a suction source. For example, in one arrangement, the aspirationchannel connects to the negative gage pressure source of the console 2.During operation, the suction source removes air from a space defined bythe aspiration channel to seal the edge of the tissue covering portionto a periphery of the tissue region of interest (e.g., to a periphery ofthe neck of a patient). For example, in one arrangement, the spacedefined by the aspiration channel includes the volumetric space betweenthe periphery of the tissue region of interest and the aspirationchannel, as indicated in FIG. 4. By sealing the edge of the tissuecovering portion to the periphery of the tissue region of interest, theaspiration channel minimizes leakage of the pressurized fluid beyond theedge of the tissue covering portion.

While the above-described arrangement of the body-cooling deviceindicates that the body-cooling device covers a body portion of apatient, such as a patient's neck, such indication is by way of exampleonly. In one arrangement, the body-cooling device 6 is configured tosurround substantially an entire body surface of the patient. Forexample, the body-cooling device is configured as a bag or a pouchdefining an edge having an aspiration channel. In one arrangement, thepouch is configured to surround at least a portion of a limb, (e.g., armor leg) of the patient. During operation, the aspiration channel sealsthe edge of the pouch to the limb while cooling fluid circulates withina fluid circulation space defined between the limb and an interiorsurface of the pouch. In another arrangement, the pouch is configured asa body suit to surround the body surface of a patient. For example, insuch a configuration, the body suit surrounds the arms, legs, pelvis andtorso of a patient. During operation, the aspiration channel seals theedge of the pouch to a neck area of the patient while cooling fluidcirculates within a fluid circulation space defined between the body(e.g., hands, arms, feet, legs, pelvis, and torso) of the patient and aninterior surface of the pouch. Such a configuration reduces the corebody temperature of the patient while minimizing leakage of the coolingfluid beyond the edge of the body suit.

As indicated above, the neck-cooling device 90 has a heat transfermembrane 33. During operation, jets of fluid 40 are directed at theinner surface of heat transfer membrane 33 and create fluid turbulenceat the inner surface of heat transfer membrane 33. Such turbulenceincreases the heat transfer from the patient's body, across heattransfer membrane 33, and into cooling fluid contained in fluidcirculation chamber 44. Such a configuration of the neck-cooling device90 is by way of example only. In one arrangement, the neck-coolingdevice 90 is configured similar to the cooling cap 15. For example,after a user applies the neck-cooling device 90 to a patient's neck, acooling fluid flows into a fluid circulation space defined between theneck-cooling device 6 and the patient's neck such that the cooling fluiddirectly contacts the patient's neck. In such an arrangement, theneck-cooling device 90 also has an aspiration system to scavenge thecooling fluid (e.g., saline) from the fluid circulation space.

In one arrangement, the neck-cooling device 90 forms part of a headimmobilizer device (e.g., a device that provides head and cervicalimmobilization). In such an arrangement, the head immobilizer deviceprovides both neck cooling to a patient at risk for ischemic injury andminimizes inadvertent motion of the patient's head during operation ofthe neck-cooling device 90.

As indicated above, the head-cooling device 1 and the neck-coolingdevice 90 are formed as distinct (e.g., separate) devices that providecooling to a patient's head and neck, respectively. In one arrangement,the head-cooling device 1 and the neck-cooling device 90 are integratedinto a single unit having a single connector, or umbilical, thatprovides cooling fluid from the console 2 to the integrated unit. In onearrangement, the head-cooling device 1 and neck-cooling device 90 areprovided in a variety of sizes to accommodate a variety of head sizesand neck sizes, such as corresponding to a patient's age (e.g., newbornto adult).

As indicated above, the head-cooling device 1 is configured such thatcooling fluid enters the fluid circulation space defined by thehead-cooling device 1 and the patient's head via multiple jets 20. Sucha configuration is by way of example only. In another arrangement, thecooling fluid enters the fluid circulation space and directly contactsthe scalp without the use of jets. For example, in one arrangement,fluid enters the infusion manifold 16 via inlet tube 4 and flowsdirectly to the patient's scalp.

As indicated above, the cooling system has a body temperature sensor 10removably connected to console 2 by a body temperature sensor lead 11.The cooling system 100 utilizes the body temperature sensor 10 tomodulate patient cooling in order to maintain the patient's body at apredetermined hypothermic temperature. In one arrangement, the coolingsystem 100 includes physiological sensors placed on or into the patientto monitor body cooling and control the operation of the console so asto control body cooling. For example, the cooling system 100 includeselectrocardiogram (EKG) sensors or pulse oximetry sensors for attachmentto the patient to aid in adjusting or maintaining the patient's bodytemperature.

As described above, the console 2 provides a cooling fluid to a fluidcirculation space located between the head-cooling device 1 and thepatient's head, via a positive gage pressure source to induce systemichypothermia in the patient. In one arrangement, the console 2 allows auser to select (e.g., set) a predetermined body temperature prior to theinitiation of therapy or during therapy. For example, using a controlpanel of the console 2, the user programs into a memory (e.g., computermemory) associated with the console 2 a target temperature of thepatient. Based upon a feedback loop created between the body temperaturesensor 10 (e.g., as placed on the patient) and the console 2 and basedupon the target temperature stored in the console's memory, the consoleautomatically adjusts the amount or rate of delivery of the coolingfluid to the patient. In one arrangement, the console 2 allows the userto select a rate at which the patient's body is cooled or re-warmed.

In one arrangement, the cooling system includes interlocks that preventoperation of the system 100 if the user does not operate the system 100correctly or if the system 100 malfunctions. For example, assume theuser incorrectly programs the console 2 to induce a hypothermictemperature within the patient that could potentially damage thepatient. In such an arrangement, based upon the detection of an impropertemperature, the interlocks of the cooling system 100 become activatedand prevent operation of the cooling system 100 (e.g., prevent deliveryof the cooling fluid to the patient).

In one arrangement, control panel of the console 2 includes userfeedback mechanisms that provide to the user the status of the patientduring induction of systemic hypothermia. For example, the control panelof the console 2 includes an electronic display or mechanical indicatorthat provide the user with information regarding the operation of thesystem, activation of one or more interlocks, or the status of thepatient's body cooling.

As indicated above, the console 2 of the cooling system 100 includes apositive gage pressure source (e.g., fluid pump) and a negative gagepressure source (e.g., aspiration pump) to respectively provide andremove fluid from the fluid circulation space 25. Such an arrangement isby way of example only. In another arrangement, the console has threepumps: a positive gage pressure source to provide cooling fluid to thecirculation space 25 of the head-cooling device, a first negative gagepressure source to provide a seal about the rim of the head-coolingdevice, and a second negative gage pressure source to assist the egressof water from the fluid circulation space 25.

As indicated above, the aspiration channel 21, in one arrangement, isdisposed about the entire circumference of the inner surface 102 at thebottom edge (e.g., rim 110) of the head cap 15 and, in one arrangement,is sized such that the inner diameter of aspiration channel 21 asdefined by the inner diameter of inner seal 22 and/or outer seal 23 isapproximately 2 to 30 percent smaller than the circumference of thepatient's head 29. Since the circumference of the aspiration channel 21is smaller than the patient's head 29, the force generated by theaspiration channel 21 on the patient's head maintains the head cap 15 onthe patient's head during operation of the cooling system 100 andminimizes cooling fluid from leaking past the rim of the head cap 15during operation. Such an arrangement is by way of example only.

In one arrangement, during operation, a portion of the cooling fluidwithin the fluid circulation space 25 contacts the inner seal 22 and theouter seal 23 of the aspiration channel 21 in a location between theseals 22, 23 and the patient's head 29. In such an arrangement, thecooling fluid contributes to sealing the aspiration channel 21 againstthe patient's head, thereby minimizing cooling fluid from leaking pastthe rim of the head cap 15 during operation. In another arrangement, theinner seal 22 and the outer seal 23 of the aspiration channel 21 eachhave a fluid resistant coating, such as a gel, grease, or adhesive,located between the seals 22, 23 and the patient's head 29. The fluidresistant coating contributes to sealing the aspiration channel 21against the patient's head, thereby minimizing cooling fluid fromleaking past the rim 110 of the head cap 15 during operation of thecooling system 100. In another arrangement, the rim 110 of the head cap15 includes a constricting band disposed about the circumference of thecap 15. For example, in one arrangement, the constricting band is adrawstring in communication with, and disposed about the circumferenceof, the cap 15. Prior to operation of the cooling system 100, a usertightens the drawstring of the cap 15 to compress the cap 15 against apatient's head 29. Such compression minimizes cooling fluid from leakingpast the rim 110 of the head cap 15 during operation of the coolingsystem 100.

As indicated above, the cap 15 of the head-cooling device 1 is formed asa rigid structure (e.g., thermoplastic) or as a flexible structure(e.g., elastomer). In one arrangement, the head-cooling device 1 isformed of a radio-translucent material to allow a user (e.g., medicaltechnician) to perform an X-ray or CT scan on a patient wearing thehead-cooling device 1 without requiring removal of the head-coolingdevice 1. In one arrangement, the head-cooling device 1 is configured todecompose or destruct after a single use to minimize reuse of thehead-cooling device 1. For example, in one arrangement, when exposed tosterilization, such as through autoclaving, the material of thehead-cooling device 1 degrades (e.g., becomes damaged), therebyindicating prior use of the head-cooling device 1.

FIG. 37 illustrates an arrangement of a cooling system 100 havingcardiopulmonary resuscitation equipment as part of the console 2. Insuch an arrangement, the cooling system 100 has a console 2, ahead-cooling device 1, an umbilical 13 connecting the head-coolingdevice 1 to the console 2, a temperature sensor 10 in electricalcommunication with the console 2 via lead 11, and defibrillatorelectrode paddles 300 in electrical communication with the console 2 viadefibrillator leads 302. The console 1 has defibrillator lead connectors304 coupled to a defibrillator 306 associated with the console 1. Thedefibrillator lead connectors 304 provide electrical communicationbetween the defibrillator paddles 300 and the defibrillator 306 of theconsole 2.

The cooling system 100 of FIG. 37 allows resuscitation of a patientstricken with cardiac arrest. For example, during operation, a user(e.g., medical technician) carries the cooling system 100 to a patientundergoing cardiac arrest. The user applies the defibrillator paddles300 to the patient, engages the defibrillator 306 of the console 1(e.g., places the defibrillator in an “on” mode of operation), anddefibrillates the patient. The user places the head-cooling device onthe patient's head, places the temperature sensor 10 on or into thepatient's body, and connects the temperature sensor 10 to the console 2using the lead 11. The user connects the head-cooling device 1 to theconsole 2 using the umbilical 3. The user activates the console 2 toprovide cooling fluid to the head of the patient to minimize ischemicinjury in the patient.

While FIG. 37 illustrates the console as having a defibrillator 306 ascardiopulmonary resuscitation equipment, such illustration is by way ofexample only. In one arrangement, the console 2 includes cardiopulmonaryresuscitation equipment such as a chest compression system (CPR system).In another arrangement, the console 2 includes cardiopulmonaryresuscitation equipment (e.g., ventilation equipment), such as acardiopulmonary ventilation system. The CPR system and the ventilationsystem allow a user (e.g. medical technician) to attempt to restorecirculation of blood in, and provide oxygen to, a patient such as apatient undergoing cardiac arrest.

FIG. 38 illustrates an arrangement of the cooling system 100. Coolingcap 401 is connected to console 402 by an umbilical comprising coolingfluid inlet tube 403, and aspiration tube 404. Cooling cap 401 consistsof inner liner (FIG. 40), outer liner 409, chin strap 408, and umbilicalcomprising cooling fluid inlet tube 403 and aspiration tube 404, andtube fittings 405. Components of the console 401 depicted are theconsole case 412, carrying handle 410, on/off switch 406, electricalbattery recharging contacts 407, and tube fitting receptacles 411. Theinternal components of the console are described later. The cooling cap401 is removably connectable to console 402 by tube fittings 405 mountedon the end of cooling fluid inlet tube 403, and aspiration tube 404, andby tube fitting receptacles 411 mounted on console 402. Tube fittings405 and tube fitting receptacles 411 are readily commercially available.Chinstrap 408 holds cooling cap 401 to the patient's head. Outer liner409 is an insulating cover made from closed cell foam with a woven outercovering. Chinstrap 408 is bonded to outer liner 408 by thread andadhesive. Console 402 provides cold saline to cooling cap 401 underpressure through cooling fluid inlet tube 403, and removes saline fromcooling cap 401 by providing suction to cooling cap 401 throughaspiration tube 404. The system is turned on and off by on/off switch406. An internal electrical battery (not shown) may be recharged by arecharging cradle (not shown) through electrical battery rechargingcontacts 407. The console, in one arrangement, is approximately eighteeninches long, twelve inches high and eight inches deep and weighs between6 and 15 pounds. Carrying handle 410 allows the console 402 to becarried my emergency medical personnel in close proximity to the patientduring patient transport.

FIG. 38 also illustrates a cooling collar 413 connected to console 402by an umbilical comprising cooling fluid inlet tube 414, and coolingfluid return tube 415. The cooling collar 413 is removably connected tothe console 402 by tube fittings 416 mounted on the end of cooling fluidinlet tube 414, and cooling fluid return tube 415, and tube fittingreceptacles 417 mounted on console 402. Tube fittings 416 and tubefitting receptacles 417 are readily commercially available. Console 402provides cold saline to cooling cap 401 as described in FIG. 38, andalso provides cold saline to cooling collar 413 under pressure. The coldsaline circulates through channels in the wall of cooling collar 413 tocool the neck of the patient (see FIGS. 41 and 42) and returns to theconsole through cooling fluid return tube 415.

FIG. 39 depicts the inner liner 418 of cooling cap 1 (FIG. 38). Innerliner 418 consists of inner shell 425, and outer shell 426. Inner shell425 and outer shell 426 are molded from an elastomer material such assilicone rubber. Inner shell 425, and outer shell 426 are bondedtogether with adhesive. Channels molded in inner shell 425 form fluidchannels 421, and aspiration channel 423 once the inner shell 425, andouter shell 426 are bonded together. Inlet manifold 419 is in fluidcommunication with fluid channels 421. Aspiration manifold(s) 20 are influid communication with aspiration channel 423. Inlet manifold isconnected to cooling fluid inlet tube 3 (FIG. 38) with tube fitting (notshown). Aspiration manifold(s) is connected to aspiration tube 404 (FIG.38) with tube fitting (not shown). Fluid jets 422 are locatedincrementally along fluid channels 421 as shown. Aspiration ports 424are located incrementally along aspiration channel 423 as shown. Coldsaline enters inner liner 318 through inlet manifold under pressure asprovided by console 402, and cooling fluid inlet tube 3 (FIG. 38). Thecold saline is distributed through the walls of inner liner 418 by fluidchannels 421. The cold saline exits fluid channels 421 through fluidjets 422 which direct the cold saline at the patient's head. Coolingjets 422 are holes through the wall of inner shell 425 and are sizedsuch that the cold saline exits the fluid channel with sufficientvelocity that the saline penetrates the patients hair, and reaches thepatients scalp. Fluid jets are between 0.010 and 0.040 inches indiameter. The inner liner 418 contains between 25 and 150 fluid jets 422which provides for even distribution of saline about the patient's head.Cold saline is provided to the inner liner 418 at a pressure of between5 PSI and 50 PSI by the control console 42 (FIG. 38). Suction is appliedto aspiration manifold(s) 420 by the console 402 and aspiration tube 404(FIG. 38) which is in fluid communication with aspiration channel 423.Air and saline are drawn into aspiration channel 423 through aspirationports 424 and is returned to console 402 through aspiration tube 404(FIG. 38). The combination of suction, and the construction ofaspiration channel 423 as shown when placed on a patient's head inducesa pressure between the patient's head and inner liner 418 belowatmospheric pressure thereby containing the saline under the inner liner418.

FIG. 40 depicts a front view of cooling collar 413. Cooling collar 413consists of cooling fluid inlet tube 414, cooling fluid return tube 415,inlet manifold 427, outlet manifold 428, cooling channels 429 formedbetween inner layer 434 (opposite surface shown), and outer layer 433,Velcro® hook 430 (opposite surface shown), Velcro® loop 431, andtracheotomy hole 432. Cold saline is supplied to cooling collar 413 byconsole 402 (FIG. 38) under pressure through cooling fluid inlet tube414. Cold saline enters cooling collar 413 through inlet manifold 427,then flows through multiple cooling channels 429 as shown, and exitscooling collar 413 through outlet manifold 428, and is returned toconsole 2 (FIG. 38) through cooling fluid return tube 15. Cooling collar13 is wrapped around the patient's neck in a circular manner and fastedwith Velcro Hook® 430, and Velcro® loop 431. Tracheotomy hole 432 ispositioned over the patient's trachea to provide for emergencytracheotomy. Inner layer 434 is bonded to outer layer 433 by adhesive,or by a thermal bonding method depending on the material selected forthe inner layer 434, and outer layer 433. Cooling channels are formed bymasking, where there is no bond between inner layer 434, and outer layer433. Inner layer 434 is formed from a sheet of polymer, or metal foil,or a lamination of polymer and metal foil. Inner layer 434 is between0.001 and 0.008 inches thick. Outer layer 433 is formed from a sheet ofpolymer and is between 0.015 and 0.125 inches thick. Inlet manifold 427,and outlet manifold 428 are integrated into the cooling collar 413during the bonding process (see FIG. 42). Velcro® hook 30, and Velcro®loop are bonded to cooling collar 413 with adhesive and thread. Coolingfluid inlet tube 414, and cooling fluid return tube 415 are made fromvinyl tubing or a suitable equivalent and are 0.25 to 0.375 inches indiameter and have a wall thickness of 0.010 to 0.060. Fluid fittings(not shown) mounted on opposite ends of cooling fluid inlet tube 414,and cooling fluid return tube 415 provide removable connection toconsole 402 (FIG. 38). FIG. 41 depicts a side view of cooling collar413. Cooling collar 413 is between 4 and 6 inches high, and has a lengthof between 12 and 20 inches to accommodate the circumference of avariety of patient's necks. The construction of the Velcro® fasteningmeans 430 and 431 as shown provides for proper fit among variouspatients.

FIG. 42 depicts in sectional view the attachment of both the inletmanifold 427, and outlet manifold 428 to cooling collar 413. Coolingfluid inlet tube 414 is joined to inlet manifold 427 using adhesive 437,or a barbed tube fitting (not shown). Spacer 435 separates inner layer434 from outer layer 433 about the circumference of manifold stem 439.Hole 438 is in radial alignment with a hole (not shown) in spacer 435.Inner liner 434 is sandwiched between spacer 435 and washer 436. Theassembly is held together with adhesive 437, or is thermally bondedtogether. Cold saline flows from cooling fluid inlet tube 414 into inletmanifold 427, though hole 438, and through hole (not shown) in space 435and into fluid channels 429.

What is claimed is:
 1. A head-cooling device for inducing hypothermiacomprising: a cap adapted to at least partially surround a patient'shead and having at least one inner seal for sealing the cap against thepatient's head to define a fluid circulation space into which a coolingfluid can be introduced to contact the patient's head; at least oneinlet for introducing the cooling fluid into the fluid circulationspace; at least one fluid outlet for withdrawing the cooling fluid fromthe fluid circulation space; and at least one vent comprising a checkvalve, to open the fluid circulation space to the atmosphere forintroducing air into the fluid circulation space.
 2. The head-coolingdevice of claim 1 wherein the inner seal further comprises at least onesealing member for sealing the fluid circulation space.
 3. Thehead-cooling device of claim 1 wherein the inner seal further comprisesan aspiration channel.
 4. The head-cooling device of claim 3 wherein theaspiration channel cooperates with the at least one fluid outlet toremove fluid and/or air at a rate sufficient to inhibit leakage from thefluid circulation space.
 5. The head-cooling device of claim 1 whereinthe vent is configured to maintain the pressure within the fluidcirculation space at substantially atmospheric pressure.
 6. Thehead-cooling device of claim 1 wherein the cap further includes at leastone rib or stud on an inner surface of the cap to maintain the fluidcirculation space.
 7. The head-cooling device of claim 1 furthercomprising a body-cooling device in fluid communication with the capsuch that the cooling fluid can flow into and out of the body-coolingdevice, which body-cooling device optionally further comprises at leastone heat transfer membrane configured to cover a body portion.
 8. Thehead-cooling device of claim 7 wherein the body-cooling device furthercomprises a neck-cooling device.
 9. The head-cooling device of claim 1wherein the cap further comprises a flexible material.
 10. Thehead-cooling device of claim 1 wherein the cap further comprises asubstantially rigid shell.
 11. The head-cooling device of claim 1wherein the at least one inlet or the at least one fluid outlet or bothfurther comprises a swivel joint configured to allow rotation of aninlet connector or outlet connector relative to the head-cooling device.12. The head-cooling device of claim 1 wherein the device furthercomprises a fluid distribution manifold removably coupled to the atleast one inlet of the head-cooling device, the fluid distributionmanifold configured to distribute the cooling fluid from a fluid sourcewithin the fluid circulation space.
 13. The head-cooling device of claim1 wherein the at least one inlet further comprises at least one jet forcreating fluid turbulence within the fluid circulation space.
 14. Thehead-cooling device of claim 1 wherein the cap comprises at least oneflow channel protrusion extending from an inner surface of the cap, theat least one flow channel protrusion configured to direct fluid flowwithin the fluid circulation space.
 15. The head-cooling device of claim1 wherein the cap comprises at least one head support disposed on aninner surface of the cap.
 16. A cooling system for inducing hypothermiacomprising: a head-cooling device having: a cap adapted to at leastpartially surround a patient's head and having at least one inner sealfor sealing the cap against the patient's head to define a fluidcirculation space into which a cooling fluid can be introduced tocontact the patient's head; at least one inlet for introducing thecooling fluid into the fluid circulation space; at least one fluidoutlet for withdrawing the cooling fluid from the fluid circulationspace; and at least one vent comprising a check valve, to open the fluidcirculation to the atmosphere for introducing air into the fluidcirculation space; and a console having a fluid reservoir to hold acooling fluid, and fluid conduits to couple the console and coolingdevice together for circulation of a cooling fluid therebetween.
 17. Thecooling system of claim 16 wherein the console further comprises atleast one pump to deliver cooling fluid from the reservoir to thehead-cooling device.
 18. The cooling system of claim 16 wherein theconsole further comprises at least one negative pressure source toremove cooling fluid from the head-cooling device.
 19. The head-coolingdevice of claim 1 wherein the at least one inlet, the at least one fluidoutlet, and the at least one vent are each coupled to the cap atdifferent locations around the cap.
 20. The head-cooling device of claim1 wherein the at least one ent substantially prevents the cooling fluidfrom exiting the fluid circulation space through the at least one vent.21. The cooling system of claim 16 wherein the fluid reservoir and thehead-cooling device form a closed loop fluid circulation system.